The Food and Drug Administration is stepping up scrutiny of infusion drug pumps, which are used to deliver precision doses of medication in hospitals, clinics and at home. The agency said that in the past five years, it has received more than 56,000 reports of adverse events associated with the pumps, including serious injuries and more than 500 deaths.
According to an FDA press release, “many of the reported problems appear to be related to deficiencies in device design and engineering.”
Between 2005 and 2009, there were 87 infusion pump recalls because of safety concerns, the agency said.
The FDA warned manufacturers that new devices would likely have to show increased evidence of safety in order to get market approval. The agency also published draft guidance to manufacturers, suggesting they provide additional design and engineering information during the approval process.
As a type 1 diabetic I am very concerned with the safety of infusion pumps. I am also concerned that FDA is issuing too many guidance doucments and not enough regulations. I address this in my blog, GxP Perspectives at: http://carl1anderson.wordpress.com/
Thank you,
Carl-