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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

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FDA MedWatch Intravia Containers by Baxter Recall

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FDA Medwatch Alert 10-20-14

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FDA Hearing Examines Impact of Anesthesia on Pediatric Patients

Friday, March 11, 2011

 

On March 10, the Food and Drug Administration (FDA) Anesthetic and Life Support Drugs Advisory Committee met. The purpose of the meeting was to  (1) receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.

The multidisciplinary committee reviewed existing and in-progress clinical research before proceeding into discussion.  The discussion addressed the application of current research to clinical practice, future directions for research, the need for funding and collaboration, and communication of the current state of knowledge to parents.

Although the committee concluded that existing literature suggests there may be an issue of concern with sedation and anesthesia related neurotoxicity in pediatric patients, they said this information is insufficient to draw a definitive conclusion. The Committee emphasized that a large inbalance between studies performed on animals (90 percent) and studies performed on humans (10 percent) exists which makes it difficult to determine sufficient risk levels for sedative exposure in young children. 

The ASA submitted a joint statement in collaboration with the American Academy of Pediatrics (AAP) and the Society for Pediatric Anesthesia (SPA) that was read to the committee. The following is an excerpt from the statement; the entire statement can be viewed here

“ASA believes patient safety is the essence of anesthesiology.  We take very seriously the faith and trust that patients and their families place in us. For each child who requires anesthesia or sedation, anesthesiologists craft a carefully considered plan using the best, most current information to minimize discomfort and maximize safety. Unfortunately, the potential for harm exists despite anesthesiologists’ best efforts and current state of knowledge. We believe that we can best protect our patients from harm by continuing to pursue the very best science that informs our practices.”


 

 

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