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 institutions 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 CDCs 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, wouldnt 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, doesnt 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 thats 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 dont 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.
So, as clinicians look inward to their particular experiences with needleless connectors, manufacturers are scrambling to obey the FDAs mandates, and the timeline leaves infection preventionists wondering when theyll have actionable data.
We would have liked the FDA to have acted years ago, says Jarvis. I communicated with people at the FDA probably seven or eight years ago about this, so its unfortunate that so much time has passed. The other issue is that I think infection control practitioners and clinicians need to perhaps be a little more aggressive in their willingness to link a product with an adverse outcome. There have certainly been enough institutions that have seen an increase in their CRBSI rates when adopting certain devices, and they need to communicate that to the FDA. The FDA is only going to act if it is under pressure to do so, and has data from the field. They have somewhat put the infection control community in a bind by saying we think theres a problem with these connectors, we are going to ask the manufacturers to do some studies, and were not going to have an answer until at least three years from now. I think there are many areas in infection prevention and control where this is the case people need to know what to do today and why arent the CDC, the HHS, SHEA or APIC mandating it today? We have been focusing on the insertion and maintenance bundles for the prevention of CRBSIs for some time now -- we know what to do, so do it now.
The Society for Healthcare Epidemiologists of America (SHEA) and the Infectious Disease Society of America (IDSA) have recommended against using positive displacement needleless connectors with mechanical valves without a thorough assessment of risks and benefits. Additionally, there have been multiple clinical reports since 2006 showing an association between the introduction of positive displacement needleless connectors into a hospital or unit and an increased rate of BSI, followed by a reduction in BSI after changing to another type of needleless connector. However, limitations in study design make it difficult to gauge the true risk of BSI associated with positive displacement connectors. For example, the studies focused on BSI in the hospital or unit rather than detection of BSI associated with a specific device; lacked information about all positive displacement connectors; and lacked adjustment for patient case mix, demographics, season of the year, cleaning practices, and other potential influencing factors.
Because there is presently insufficient information to determine if positive displacement connectors increase the risk of BSI compared with other needleless connectors, FDA is requiring the companies to conduct post-market surveillance studies to provide an assessment of the risk associated with positive displacement needleless connectors. Manufacturers must answer two public health questions about positive-displacement needleless connectors with their post-market surveillance studies:
-- What is the rate of bloodstream infections for subjects receiving your positive displacement connector for central line access and is it statistically non-inferior to the rates seen in subjects receiving other needleless connectors (e.g., negative, neutral, or split-septum connectors) for central line access, given comparable patient populations?
-- Are there patient demographics, co-morbidities/severity of illness, or device cleaning practices for which placement of your positive displacement connector for central line access increases subjects risk of bloodstream infections compared with other needleless connectors?
Theres no doubt that this FDA action is a challenge for the manufacturers as well as clinicians, Jarvis says. The FDA is essentially telling them they need to do this study, and I think within 30 days they need to provide the FDA with a game plan for how they are going to conduct this post-market surveillance study. If you are a small manufacturer, how are you going to do that? Its quite a challenge because so many hospitals are using these devices. And with the FDA saying it will be about a three-year wait for data and who knows how long after that data will be available for a conclusion -- what about our patients during that time?
Clinicians who have questions may contact Mary Beth Ritchey, RN, MSPH, PhD, in the Division of Epidemiology at the Office of Surveillance and Biometrics, CDRH, by e-mail at [email protected], or by telephone at (301) 796-6638.