FDA Advisory on Compatibility Problems Associated with Needleless Intravenous Access Systems

  • Date: November 29, 2010
  • Source: Admin
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FDA has issued a notification to healthcare professionals - in particular those working in emergency and critical care settings. According to the notification, FDA has received reports to the effect that compatibility problems arise when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems. However, while connecting to the needleless IV access systems, the syringes may malfunction, break or get clogged up. Most of the reports concern pre-filled needleless glass syringes that contain adenosine, generally while attempting to connect to some pin-activated needleless IV access systems. Adenosine is administered to restore heart rhythm to normal. It must be injected swiftly into the blood stream in an emergency lest it should delay the treatment. 
At times, while being connected to pin-activated needleless IV access systems, the syringe may cause the pin to break, thus clogging the syringe or damaging the IV tubing and / or the needleless connector. Intravenous access has to be established again, as a result. Overall, a delay in administration of the medication may result, which could potentially harm the patients. 
Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. Problems concerning certain pre-filled needleless glass syringes containing amiodarone have also been reported to FDA. FDA has issued a letter furnishing a list of affected adenosine and amiodarone products.
FDA’s recommendations
FDA has therefore recommended that healthcare professionals, risk managers and staff who buy, stock or administer emergency crash cart medications, operating room medications, emergency drug boxes or types of emergency drug caches be alerted to the said incompatibility and the resultant potential for damage or blockage of the IV line and delay in administering the medication. Healthcare organizations stocking glass prefilled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes by way of backup. 
The FDA is reviewing all pre-filled needleless glass syringes meant for use with needleless intravenous access systems because any delay could be potentially life-threatening. It has advised healthcare professionals and healthcare organization managers to report the nature of syringe failure, any unfavorable patient outcomes and any mitigation measures that have been initiated by users of the said products. 
In early August 2010, the FDA asked the following nine companies to conduct a post-market surveillance study on positive displacement needleless connectors to assess whether they may be associated with a higher rate of device-associated bloodstream infections than other types of needleless connectors, and to assess the factors that may contribute to a possible increased risk:
Amsino International, Inc 
Baxter Healthcare Corporation
Becton Dickinson Infusion Therapy Systems Inc
B. Braun Medical Inc
Cardinal Health  
CareFusion Corporation   
Critical Device Corporation  
ICU Medical, Inc   
Medegen Medical Manufacturing Services  
Incidentally, the Society for Healthcare Epidemiologists of America (SHEA) and the Infectious Disease Society of America (IDSA) have advised against using positive displacement needleless connectors with mechanical valves without a thorough assessment of risks and benefits. 

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