Wednesday, August 4, 2010

FDA releases a "Dear ICP" letter for positive displacement needleless connectors

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

3 comments:

  1. Do you think ICU Medical's new neutral pressure needleless connector will help here? http://tinyurl.com/23xgbzo

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  2. There is much misinformation and misunderstanding about connectors. There are two categories of connectors Needlefree and intraluminal protection. Within the needlefree category are two types, those with reflux with disconnection and those with reflux with connection. Reflux is associated with occlusion and catheter related blood stream infection. this is because the reflux coats the inner wall and provides the surface conditioning necessary for bacteria to adhere, colonize and develop biofilm. Needlefree connectors were never designed to protect the intraluminal fluid pathway. They were designed to eliminate needle sticks. As the IV route has become the main choice for therapeutic regimens, there has been increases in CR-BSI. Until the last few years all care focus has been on insertion and dressing management. It is now understood that without intraluminal protection, elimination of CR-BSI is impossible. The PPMVs have the most dead space, the most tortuous pathway, and have been clinically shown to be associated with increased infections. However, Dr. Jarvis Dec. 09 and recently in the august infection control journal has stated that all NF connectors have problems. In 2004 a connector entered the market with design features that would minimze bacterial migration and minimize fibrin adhesion. These design features include a tight fitting septum that is made of a hydrophobic material that enables swabbing success, a double microbial barrier that provides pathway protection when not in use, a straight fluid pathway, no dead space and no reflux on connector or disconnection. This feature means that there is no associated clamping sequence required to be performed by nurses. RyMed Technologies manufactures this connector - InVision-Plus. RyMed is the only company not sited by the FDA.

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  3. The answer to Tracy is, we have no independent data to show IaUs new product works in clinical nor that that the devise fits the definition of neutral (no relux of blood on connection or disconnection). Time will tell when used with blood.
    To comment on Plsysinc, I am glad you have placed this information as i often find people very confused about this issue. As for dead space, if you have any at all it will grow bacteria. A good clinial question to ask manufacturers, for those of us who help buy products for our institutions, would be how much dead space does your conector have?

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