FDA Class I Recall: Symbiq Infusion Pumps

There is an FDA Class I recall of Symbig Infusion Pumps One channel, model 16026 and Dual channels, model 16027 made by Hospira due to the potential for unrestricted flow of fluid or medication if the administration set (cassette) is removed before the cassette carriage fully opens and the slide/roller clamp is not closed. Additionally,…

2010 NIOSH List Antineoplastic/Hazardous Drugs

The National Institute of Occupational Safety and Health (NIOSH) released an update to the 2004 sample list of hazardous drugs. The 2010 list supersedes the 2004 list and includes 21 additional drugs.  According to ASHP [1990] the definition of hazardous drugs:1. Carcinogenicity 2. Teratogenicity or other developmental toxicity 3. Reproductive toxicity4. Organ toxicity at low…

FDA Safety Alert on Nimodipine: Not for IV use

Nimodipine is a medication intended to be given in a critical care setting to treat neurologic complications from subarachnoid hemorrhage and is only available as a capsule. The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals that nimodipine capsules should be given ONLY by mouth or through a feeding tube (nasogastric tube). This…

FDA Requires Baxter to recall Colleague Infusion Pump

On July 13, 2010, the U.S. Food and Drug Administration required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination. According to the FDA, it is requiring Baxter to provide…

Epinephrine – Warning Risk for Serious or Fatal Medication Errors

Please note this urgent message from the National Alert Network (NAN) for Serious Medication Errors.   The National Council for Medication Error Reporting and Prevention (NCCMERP) is distributing a NAN alert to warn practitioners about the potential for serious or fatal errors with epinephrine, caused by the current shortage of epinephrine emergency syringes. EPINEPHrine emergency syringes…

FDA Alert on certain IV medications

The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination. FDA has received reports of floating matter in IV bags manufactured by Claris Lifesciences Limited, in Ahmedabad, India. Microbiological analysis identified the matter in one of the bags…

FDA Infusion Pump Improvement Initiative

External infusion pumps, commonly called “infusion pumps”, including large volume, patient-controlled analgesia (PCA) , elastomeric , syringe , enteral, and insulin pumps, are used worldwide in healthcare facilities such as hospitals, and in the home.  Infusion pumps have contributed to improvements in patient care, allowing for a greater level of control, accuracy, and precision in…

Informed consent for Infusions of Biologics

A common question I get asked by nurses is…..do I need to obtained an  informed consent from a patient who is receiving infusions of biologic agents such as  Remicade (Infliximab)? An informed consent, according to the American Medical Association (AMA), is the communication process between a patient and his or her physician that results in…

Infusions of Monoclonal Antibodies in New York State

In the past 12 years, we have seen an increase in new monoclonal antibodies approved by the FDA for numerous indications as treatment options for cancer, neurologic disorders, immunologic,  and autoimmune diseases, to name a few. These monoclonal antibodies are administered either subcutaneously, usually self administered by patients or administered intravenously by a registered nurse…