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Health Advisory: Products recalled in response to possible epidemiologic link to Serratia marcescens bloodstream infections
Key Points
- CDPHE is investigating an outbreak of Serratia marcescens bloodstream infections among pediatric patients with central venous catheters or implantable medication ports in place at the time of their infection. Two other states have identified similar clusters; isolates in these three states are indistinguishable by pulsed-field gel electrophoresis (PFGE).
- All patients with matching isolates in Colorado and Tennessee were exposed to PosiFlush Pre-Filled Heparin Lock Flush Syringes (10 USP units/mL), and some were also exposed to PosiFlush Pre-Filled Heparin Lock Flush Syringes (100 USP units/ml), both manufactured by BD. Additionally, most patients were exposed to PosiFlush Sterile Field Saline Flush Syringes manufactured by BD.
- No product has tested positive to date with S. marcescens.
- BD has issued a voluntary recall of certain lots of BD PosiFlush Heparin Lock Flush and BD Pre-Filled Normal Saline Flush syringes due to a potential for contamination with Serratia marcescens. Specific information regarding the recall, including specific lot numbers, can be found here: http://legacy.bd.com/alerts-notices/posiflush-recall.asp
- BD has not recalled PosiFlush Sterile Field Saline Flush Syringes.
- Clinicians and healthcare facilities that use PosiFlush Pre-Filled Heparin Lock Flush Syringes (10 USP units/mL or 100 USP units/mL) or PosiFlush Sterile Field Saline Flush Syringes manufactured by BD might consider finding an alternate supply if readily available, taking into consideration the risks and benefits of using these products among vulnerable patients.
- The Centers for Disease Control and Prevention (CDC) is issuing a national call for cases:
- Clusters (i.e. more than 2 cases) at a single healthcare facility since April 1, 2018, of S. marcescens bloodstream infections in patients who have central venous catheters or ports in place, or
- Cases since April 1, 2018, of S. marcescens bloodstream infections among outpatients who have central venous catheters or ports in place.
- Please report cases meeting the above criteria to Kyle Schutz (Kyle.Schutz@state.co.us) at 303-692-2666. Please save S. marcescens isolates for possible further testing.
CDPHE was recently notified of a cluster of patients with Serratia marcescens bloodstream infections. S. marcescens is a bacteria that can cause illness, such as bloodstream infections (bacteremia) and sepsis, and has been associated with contaminated products in a number of previous nationwide outbreaks. After a national call for cases, several additional states have reported similar clusters since January 2018. Pulsed-field gel electrophoresis (PFGE) demonstrated that at least three states had strains of bacteria that were indistinguishable. All patients with PFGE-matched isolates of S. marcescens among at least two states, Colorado and Tennessee, are pediatric patients with central venous catheters or implantable medication ports in place at the time of their infection. PFGE results of S. marcescens from additional states are pending.
Among the nine patients with matching S. marcescens isolates in Colorado (five) and Tennessee (four), all patients were exposed to PosiFlush Pre-Filled Heparin Lock Flush Syringes (10 USP units/mL) manufactured by BD. Additionally, most patients were exposed to PosiFlush Sterile Field Saline Flush Syringes manufactured by BD, and some were also exposed to PosiFlush Pre-Filled Heparin Lock Flush Syringes (100 USP units/ml) manufactured by BD. Exposure data is not yet available from the third state. Other products cannot be excluded at this time. No products have tested positive for S. marcescens to date; product testing is ongoing. The specific lot numbers used on affected patients are unknown. The number of cases compared to the number of patients who likely were exposed to these products appears to be low. It is unknown if the outbreak is ongoing. CDPHE continues to investigate this evolving outbreak and is collaborating closely with other involved states, CDC, and FDA.
Recommendations/Guidance
- Clinicians should be aware of the ongoing investigation. Patients most at risk at this time appear to have central venous catheters or implantable medication ports; patients affected in Colorado and Tennessee are predominantly pediatric.
- The investigation is ongoing and data at this time are insufficient to quantify the risk of exposure to potentially contaminated PosiFlush Pre-Filled Heparin Lock Flush Syringes (10 USP units/mL and 100 USP units/mL) or PosiFlush Sterile Field Saline Flush Syringes manufactured by BD. Clinicians and healthcare facilities that use these BD products might consider finding an alternate supply if readily available, pending further investigation of the outbreak by CDPHE, other states, CDC, and FDA. The risks and benefits of use of these products among vulnerable patients should be carefully considered. Any compounding of medications must be done according to guidance and regulations. If product substitution is considered, be aware that repeated access of saline bags or multi-dose vials of heparin and unsafe compounding have been associated with bacterial and viral bloodborne pathogen outbreaks. (See: https://www.cdc.gov/injectionsafety/index.html)
- During other outbreaks of S. marcescens bloodstream infections among patients with central venous access, some bacteremic infections were delayed due to biofilm formation in the catheters. Clinicians should refer to HICPAC Guidelines for the Prevention of Intravascular Catheter-Related Infections when considering prevention of such infections. (https://www.cdc.gov/infectioncontrol/guidelines/bsi/index.html)
- CDC is issuing a national call for cases:
- Clusters (i.e: more than 2 cases) at a single healthcare facility since April 1, 2018, of S. marcescens bloodstream infections in patients who have central venous catheters or ports in place, or
- Cases since April 1, 2018, of S. marcescens bloodstream infections among outpatients who have central venous catheters or ports in place.
- Please report cases meeting the above criteria to Kyle Schutz (Kyle.Schutz@state.co.us) at 303-692-2666. Please save S. marcescens isolates for possible further testing.
The investigation is ongoing, and guidance might change.
For more information
For additional questions about this investigation, contact Sarah Janelle (Sarah.Janelle@state.co.us) at 303-692-3018.
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