Infusion Pumps - 710 deaths

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http://www.nytimes.com/2010/04/24/business/24pump.html?nl=&adxnnl=1&emc=aua21&adxnnlx=1272124865-HkVIN3II3oIYLmL3/1bd4A


F.D.A. Steps Up Oversight of Infusion Pumps


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.

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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.

A few years ago, for example, several top scientists at the center contended in letters to lawmakers that their superiors had ignored both their recommendations and policy guidelines in approving the sale of devices. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009. In that same time frame, manufacturers of infusion pumps issued 79 recalls, among the highest for any medical device.
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too late for the already dead

[Catshrink]

1. My sister's insulin pump is always jamming up.

She has to replace the port or the electronics good up. It seems every few months the manufacturer is replacing it for her. Still, she prefers it to giving herself multiple shots every day. It's such a nasty disease. There is an "artificial pancreas" in development but as I read the article, I thought of the issues raised your article. Here's an article on the artificial pancreas.

http://www.yalealumnimagazine.com/issues/2010_03/pancreas3439.html

[ensho]

2. thanks for the info

nt

[dana_b]

3. interesting

10,000 complaints is big. That could potentially have been a lot of near misses. I know our hospital just upgraded the IV pumps to include a drug library on them. That way the med, rate, dose etc. is put in and the library can tell the user if its too high, low, etc.

[ensho]

4. glad to see your hosp. is up to date on this subj.

nt