Update: FDA Orders Baxter to Recall Infusion Pumps – Not Meeting Timeline – Bar Code Tags Would Make Compliance Eas
Posted Jul 13 2010 4:23pm
The NY Times has an article today stating a letter was sent to Baxter about the recalls. About 200,000 pumps need to be recalled, this is huge. Again going back to my campaign for bar codes and their use with drugs and medical devices, their use would have made this process a lot easier for the FDA to monitor too.
We still need those tags to use technology to make this process a lot easier. Original post follows below. BD
Monday, May 3, 2010
Infusion Pump Recall For Baxter – Will Offer Exchange Sigma Spectrum for Recalled Colleague Models
Just a couple months ago recalls were announced for the Aquarius Hemodialysis systems with Baxter so this is another large recall and the good news is the upgrade with wireless on the newer units – pictured is the Sigma Spectrum pump that Baxter will offer as a replacement. Around 200,000 units will be recalled. There were numerous complaints and yet the company had asked to keep the devices in service until 2013, but the FDA said no.
I know everyone may be getting tired of my posts here about cell phones for recalled drugs and devices but I’ll keep it going and perhaps it will reach the right ear eventually and with coming out on TV Guide this week we can practice more. The same technology too is being developed to use a cell phone to input medical record information into a PHR, so it’s a bit of a natural here, easy to use too.
I’m not picking on Baxter as I hit up Johnson and Johnson with the same brain storm with their consumer product recall too. Recalls really need technology right now to help manage the process and we can’t wait much longer here. People die in some instances with getting implanted with faulty devices that have been recalled and malfunction, as a result of not getting pulled from the supply area. These are needless deaths too. BD
DEERFIELD, Ill., May 03, 2010 (BUSINESS WIRE) -- Baxter Healthcare Corporation today announced that it will recall COLLEAGUE infusion pumps from the U.S. market pursuant to an order under its existing June 2006 consent decree with the U.S. Food and Drug Administration (FDA). Baxter will work with the FDA to ensure that the recall process provides customers appropriate alternatives for supporting patients' needs.
As previously disclosed, Baxter entered into a consent decree with FDA under which the company has been pursuing remediation of the infusion pumps. The decree permits FDA to require the recall of the pumps, and FDA has communicated to the company that it will require such a recall, with the company providing monetary consideration or replacement pumps to customers on a timeline to be determined with FDA and based on medical need. Baxter intends to work with FDA to minimize disruption to healthcare facilities using COLLEAGUE pumps. Baxter anticipates that, among alternatives to be provided to customers, the company will offer to exchange Baxter's Sigma SPECTRUM infusion pumps for COLLEAGUE infusion pumps without charge to customers.