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The U.S. Food and Drug Administration (FDA) just reiterated a warning that needleless pre-filled glass syringes should not be used in emergencies. Instead, the FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers should stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or […]
The U.S. Food and Drug Administration (FDA) just reiterated a warning that <"https://www.yourlawyer.com/practice_areas/defective_drugs">needleless pre-filled glass syringes should not be used in emergencies. Instead, the FDA recommends that, to reduce the potential risks to patients, healthcare professionals and risk managers should stock crash carts, ambulances, and emergency rooms with adenosine and amiodarone supplied in vials or pre-filled plastic syringes, whenever possible.
In its May 2011 FDA Drug Safety Communication, the agency included photos, a list of affected adenosine and amiodarone products, and IV access systems known to be incompatible with adenosine and amiodarone pre-filled glass syringes. This communication can be accessed here.
The FDA is notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous (IV) access systems.
These syringes may malfunction, break, or become clogged during the process of attempting to connect to needleless IV access systems. Most of the reports have been related to pre-filled needleless glass syringes that contain adenosine, often when attempting to connect to some pin-activated needleless IV access systems.
Adenosine is a cardiac drug that is administered when a patient has a rapid or irregular heart rhythm and is used to attempt to return the heart rhythm to normal. Adenosine must be injected rapidly into the blood stream in emergency situations; this failure could delay treatment.
In some cases in which an attempt is made to connect 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, which requires reestablishment of a new intravenous access. These failures can cause a delay in administration of the medication, which could, potentially, result in serious harm to patients.
Adenosine pre-filled glass syringes are marketed by Teva, Sagent, Baxter, and Wockhardt. FDA has also received reports of problems related to certain pre-filled needleless glass syringes containing the cardiac drug amiodarone. The FDA Letter to Stakeholders on this issue lists affected adenosine and amiodarone products and can be accessed at: http://www.fda.gov/Drugs/DrugSafety/ucm234097.htm.
Healthcare organizations currently using glass pre-filled syringes should consider stocking adenosine supplied in vials or pre-filled plastic syringes as a back up measure, the FDA says. The FDA also wrote that it expanded the scope of its review to include all currently marketed pre-filled needleless glass syringes intended for use with needleless intravenous access systems in which delay in administration could potentially result in a life threatening event.