The FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps in the past five years. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.
The FDA will also sponsor a public workshop May 25-26, 2010. Participants will discuss observed safety problems, and explore opportunities to work with others, including foreign regulators, to improve the design of infusion pumps on the market or in development, in order to reduce pump malfunctions and errors.
According to the FDA press release, the most common types of reported problems have been related to:
•Software defects, including failures of built-in safety alarms;
•User interface issues, such as ambiguous on-screen instructions that lead to dosing errors; and
•Mechanical or electrical failures, including components that break under routine use, premature battery failures, and sparks or pump fires.
The FDA has the following advice for users. To help reduce infusion pump risks, consider the following general strategies:
•Plan ahead and be ready to respond in the event of a pump failure.
•Label infusion pump channels and tubing to prevent errors.
•Check infusion pump settings and monitor for signs of over- or under-infusion.
•Use available resources to prevent and respond to pump problems.
•Report adverse events promptly to the FDA.
Here is the complete report:
http://www.diabeteshealth.com/read/2010/04/27/6658/fda-launches-initiative-to-reduce-infusion-pump-risks/
