PPAG update on FDA MedWatch on BD 3 ml and 5 ml Syringes

The recent FDA MedWatch on BD syringes issued on Aug 18 has caused anxiety among hospitals that treat pediatric patients. Despite the lack of an FDA clearance for the use of these syringes as storage systems, it is a common pediatric practice to use such devices due to a lack of pediatric-appropriate and FDA-approved options. The immediate concern that should be addressed is the assessment of fentanyl dilutions that are stored in 3 mL or 5 mL BD syringes for longer than 24 hours may lose potency.  No other syringe sizes have been recently implicated and no other medications to our knowledge have been laboratory verified as sub potent.  At issue is the fact that new materials used to make the stoppers for individually packaged 3 mL and 5 mL BD syringes has changed, and the new material appears to lower the pH enough to cause fentanyl dilutions, which are very sensitive to changes in pH, to degrade more rapidly than previously tested.  BD has changed the material back to the original contents and will likely be offering exchanges on affected product. If premade fentanyl dilution syringes are provided by a compounding company, then contact that company to discuss implications of this change.  This situation has revealed previously unidentified challenges in pediatric sterile compounding that PPAG will strive to address moving forward.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458955.htm