Need for Oversight of Infusion Pumps

 Many medical devices are subject to much less scrutiny than pharmaceuticals and as my readers know the scrutiny for those leave much to be desired.  

According to the NewYorkTimes: “From 2005 to 2009, more than 10,000 complaints were received annually by the F.D.A. about the pumps.”

from the NYT by By BARRY MEIER

Federal regulators say they are moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment — automated pumps that intravenously deliver drugs, food and other solutions to patients.

 

On Friday, the Food and Drug Administration issued preliminary guidelines that will require producers of the devices, known as infusion pumps, to supply the agency with more test data on them before they can be approved for sale.

Over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices, though F.D.A. officials say they think the number may be significantly higher. Some of those deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.

An estimated two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes. The pumps use a variety of designs to intravenously deliver food, fluids and drugs like pain medications, insulin and cancer treatments.

The pump-related initiative comes as the Obama administration tries to reinvigorate the F.D.A. after years of criticism by lawmakers and others that it was a rubber stamp for industry. The F.D.A. Center for Devices and Radiological Health, which oversees scores of critical products like heart implants, imaging equipment and infusion pumps, has come under particular scrutiny.

much more via F.D.A. Steps Up Oversight of Infusion Pumps – NYTimes.com.

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