By Kelly M. Pyrek
Now that the infection prevention and control community has had some time to learn about the Food and Drug Administration (FDA)’s concerns regarding positive-displacement needleless connectors and the possible link to bloodstream infections (BSIs) and patient mortality, the question seems to be, now what?
The answer appears to lie within a healthcare institution’s own experiences with these kinds of medical devices. “I think if clinicians are using a positive-displacement needleless connector, they must examine their own situations and see if their BSI rate is higher than it should be, which should be zero, and if not, consider a change to another device,” says William Jarvis, MD, president of Jason and Jarvis Associates, LLC, a private consulting company in healthcare epidemiology and infection control, as well as former president of SHEA and former acting director of the CDC’s Hospital Infection Program (now the Division of Healthcare Quality Promotion). “Luckily though, in contrast to some other product-related situations, they do have other products that they can turn to. There are a variety of devices that have a very strong track record of being safe that they can consider.”
The FDA has become aware of information that raises concerns about the safety of positive displacement needleless connectors, which are intended for use as an accessory to an intravascular administration set to allow delivery of a wide range of fluids to a patient's vascular system through a cannula inserted into a vein or artery. Positive displacement refers to the positive pressure of fluid movement from a reservoir into the lumen of the catheter upon disconnection of an administration set or syringe. The FDA has received three reports of death associated with BSI and positive-displacement needleless connectors.
The irony is that the positive-displacement needleless connectors were designed to address healthcare worker safety, and now they are implicated in the potential jeopardy of patient safety. “The Occupational Safety and Health Administration (OSHA) mandated these needleless connectors, as it was looking at it from the healthcare worker perspective and not the patient point of view,” Jarvis says. “I think there has been a learning curve with the various devices; even when the first split septum came out there were infection control issues and increased infections until clinicians learned how to use them properly. For more than a decade now, split septum devices have had very safe usage associated with them, both for patients and for healthcare workers. Positive-displacement needleless connectors were really trying to sell several things; one is the healthcare worker protection aspect because there is no needle being used; the second is the decreased risk of infection for the patient; and the third and biggest thing is reducing occlusions which indirectly influence infection rates and may also offer the benefit of reducing heparin use.”
At this time, FDA is not recommending changes in use of positive-displacement needleless connectors. Jarvis advocates greater clinician investigation into product usage correlating with hospital data. “When I travel the country and ask clinicians who have changed from negative-displacement needleless connectors to positive-displacement devices what their occlusion rates were before product use and what they are now, I find very few people who can tell me this information. If the major benefit of that product over previous products is reducing occlusions and heparin use, wouldn’t you like to know you are actually receiving that benefit? There have been a couple of studies not published showing that when you look at partial occlusions and total occlusions for at least some of these positive-displacement needleless connectors, what they say they are going to provide, doesn’t end up happening. I think it is a double-edged sword; clinicians need to assess the device they are using and look at whether they do have an increase in infection rates and if so, are needleless connectors a possible source; and then potentially changing devices based on that information.”
The FDA is requiring nine companies to conduct a post-market surveillance study on positive-displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated bloodstream infections than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk.
“I think many of these companies believe their devices are safe if healthcare workers do the right thing over time, and that’s not realistic,” Jarvis says. “We would like healthcare workers to wash their hands 100 percent of the time, but the reality is 60 percent compliance is probably the highest we are going to get voluntarily. So we need devices that operate in a way that is going to defeat healthcare workers if they don’t use the devices correctly, whether it is disinfecting the device, flushing the device, or maintaining it, etc. The design of the device can dictate how well it functions, and the more complicated the device mechanisms are, the more gaps, the more difficult it is to disinfect and harder to flush, all contributing to the risk for infections.”
