Similar to a "Dear Doctor" letter, the FDA just sent out a "Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors" and addressed it to "Dear Infection Control Professional." My first thought was that there are no more ICPs, so someone should alert the FDA.
On a serious note, the FDA is requiring nine companies to conduct postmarketing surveillance of positive displacement needleless connectors as they have been associated with higher CLABSI rates. However, while the FDA is not recommending changing the use of these devices, they refer people to the SHEA/IDSA HAI Prevention Compendium. Since the Compendium states to "not routinely use positive‐pressure needleless connectors with mechanical valves before a thorough assessment of risks, benefits, and education regarding proper use," it appears that FDA has taken a risk-averse stance. The studies, which are expected to take up to 3 years, have to answer the following two questions:
1) 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?
2) Are there patient demographics, comorbidities/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?
Full FDA letter is here.
SHEA/IDSA HAI Prevention Compendium
Image from Edgar K. Infect Control Hosp Epidemiol, April 2009