An estimated 1,500 U.S. hospitals are in a pricey dilemma between politics and health.
On May 3, 2010, the FDA announced Baxter should recall and destroy 200,000 COLLEAGUE infusion pumps due to “longstanding failure.” It’s now May 20 and the recall of inventory has not begin. Options for the replacement of pumps have not been announced either.
From the recall:
“Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. 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.”
What’s even more bizarre is that although there is a definite recall for these particular Baxter pumps, the FDA has also stated that it is appropriate to continue to use COLLEAGUE pumps for the time being. It’s a recalled product, but everything is okay! Was this a practice recall?
Currently there is no timelime or further details of when the actual physical recall will take place. Baxter had 15 days to respond to the FDA’s April 30 letter ordering action. The FDA then has 15 days to review the Baxter response–which had 15 days from the original notice.
For those unfamiliar with the blood and pharmaceutical industry, this is very typical behavior.Â Hemophiliacs in particular have a jaded past with Baxter and a few larger companies like Bayer since back in the 80’s when they were infected with HIV (+hepatitis, +CJD, +others…). After painful legal discovery, negligence was found not only on the part of the product-making companies but the FDA as well.
ECRI Institute will announce the recall details as soon as they are made available and has published a preliminary guide for current material to Download and is encouraging hospital administrators to register to be notified of future coverage.
In the meantime, let’s hope patients are not put in the position of needing these pumps or that nurses aren’t conflicted ethically whether or not to use them.