Dear Infection Control Professional,
The Food and Drug Administration is requiring nine companies (see Attachment A) to conduct a postmarket surveillance study on positive displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated bloodstream infections (BSI) than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk.
FDA has become aware of information that raises concerns about the safety of positive displacement needleless connectors. These devices 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. Needleless connectors may also be referred to as “valves” or “accesses.” “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.
FDA has received three reports of death associated with BSI and positive displacement needleless connectors. Infection control authorities are also concerned about positive displacement connectors and the device’s association with BSI. As you may be aware, the Society for Healthcare Epidemiologists of America and Infectious Disease Society of America have recommended against using positive displacement needleless connectors with mechanical valves without a thorough assessment of risks and benefits (http://www.journals.uchicago.edu/doi/pdf/10.1086/591059).
Additionally, there have been multiple clinical reports since 2006 (see Attachment B) 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 postmarket surveillance studies to provide an assessment of the risk associated with positive displacement needleless connectors.
Manufacturers must answer the following two public health questions about positive displacement needleless connectors with their postmarket 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, 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?
These studies may take up to three years to complete. At the end of the study period, FDA will assess whether regulatory or other actions need to be taken.
At this time, FDA is not recommendingchanges in use of positive displacement needleless connectors. For practice recommendations to prevent health-care associated infections in acute care hospitals refer to the SHEA/IDSA HAI Prevention Compendium (http://www.journals.uchicago.edu/toc/iche/2008/29/S1)
Prompt reporting of adverse events can help FDA identify and better understand the risks associated with medical devices. If you suspect a problem with a positive displacement needleless connector, or any device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Questions may be directed to Mary Beth Ritchey, RN, MSPH, PhD in the Division of Epidemiology at the Office of Surveillance and Biometrics, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, by email at [email protected], or by telephone message at 301-796-6638 begin_of_the_skype_highlighting 301-796-6638 end_of_the_skype_highlighting.
Director, Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
List of companies with postmarket surveillance study ordered for positive displacement needleless connectors.
|Amsino International, Inc.||Cortez Needle Free IV Connector|
|Baxter Healthcare Corporation||IV/Catheter Extension Set with NAC Plus Needleless Access Connector and NAC Plus Needleless Access Connector|
|Becton Dickinson Infusion Therapy Systems Inc.||BD posiflowTM Positive Displacement Valve|
|B. Braun Medical Inc.||Ultrasite Valve|
|Cardinal Health 200, LLC||IVAC Needle Free Administration Sets|
|Carefusion 303, Inc.||SmartSite Needle Free Valve Administration Sets|
|Critical Device Corporation||NIMA Needleless Injectionsite Master Adapter with PosiFlow Positive Displacement Feature, and IV Sets|
|ICU Medical, Inc||CLC 2000|
|ICU Medical, Inc||CLC2000 Catheter Patency Device|
|ICU Medical, Inc||TEGO|
|Medegen Medical Manufacturing Services||Maxplus Tru-Swab Positive Displacement Connector|
|Medegen Medical Manufacturing System||MaxPlus Tru-Swab Positive Displacement Connector|
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