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FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

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FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

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FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

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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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ASA Signals Support for Drug Shortage Provisions, Urges Inclusion of language Relating to Anesthetic Drugs

Wednesday, April 25, 2012

On April 24, ASA formally communicated support to Chairman Harkin and Ranking Member Enzi of the Senate Committee on Health, Education, Labor and Pensions (HELP) for language included in the shortage provisions (Title X) of the Food and Drug Administration Safety and Innovation Act. 

ASA successfully lobbied the Committee to include language in the bill that would require manufacturers to notify the Food and Drug Administration (FDA) when there is a shortage of a "sterile injectable product" or a drug "used in emergency medical care or during surgery." ASA urged the HELP Committee to maintain this language as the bill moves forward.  

ASA supported title also includes provisions creating an inter- and intra-agency taskforce to work on drug shortage issues. Bill language also directs the Government Accountability Office (GAO) to investigate market forces contributing to drug shortages and stockpiling. ASA believes the HELP Committee's package represents an important step in Congress' effort to address the shortage of anesthetic drugs.

According to a 2011 Government Accountability Office report, anesthetic and central nervous system drugs are among the class of drugs experiencing the highest frequency of shortages at 23 percent of all shortages.  In March, ASA conducted an informal survey of 3,033 anesthesiologists regarding drug shortages.  Of those surveyed, 97.6 percent experienced a drug shortage, 96.3 percent had to use alternative drugs, 50.2 percent had to change the procedure in some way, 7.0 percent had to postpone cases and 4.1 percent had to cancel cases.  Most troubling, those that responded to the informal survey reported that six patients (0.2 percent) died as a result of a drug shortage.
 
The Committee approved the Food and Drug Administration Safety and Innovation Act on April 25 by a voice vote. This legislation will now be considered by the full Senate.
 
Read the ASA letter. 
View the HELP Committee bill.

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