Public Citizen Faults FDA On Handling Of Device Recalls
14 March 2009 - 9:30AM
Dow Jones News
The consumer advocacy group Public Citizen is criticizing the
Food and Drug Administration over the handling of three medical
device recalls this week, including a Baxter International Inc.
(BAX) pump used to deliver medication and fluids to patients.
Sidney Wolfe, the director of Public Citizen's health research
group, said the agency is taking too long to notify the public
about such recalls, and should exercise its authority to force
companies to address problems with devices under strict timelines
rather than allowing companies to voluntarily recall devices.
For example, on Wednesday, the FDA classified Baxter's Jan. 23
voluntary recall of its Colleague intravenous fluid pumps as Class
I, or the most serious type of recall. Baxter issued a press
release on the matter Wednesday while the FDA posted a notice about
the recall to its Web site later that day. (Baxter sent a recall
notice to customers on Jan. 23.)
In a letter sent Thursday to Acting FDA Commissioner Frank
Torti, Wolfe asked, "Why did it take the FDA until March 11th,
nearly seven weeks, to decide that this problem was serious enough
to merit being classified as a Class I recall, that is, one in
which the FDA states 'there is a reasonable probability that use of
the product will cause serious injury or death.'" Wolfe noted that
Baxter has had a series of recalls involving the Colleague pump
including battery and alarm failures.
Baxter hasn't sold any new Colleague pumps in the U.S. since
2005 while it has attempted to address various problems, but about
200,000 existing pumps remain.
FDA spokeswoman Siobhan DeLancy said because the majority of
infusion pumps on the market were made by Baxter, requiring them to
be removed would create a shortage.
Earlier this week, the FDA posted a notice on its Web site about
a Jan. 14 Covidien Ltd. (COV) recall of involving 21 lots of a
pediatric tracheostomy tube when it classified that recall as Class
I, or about two months after the recall started.
Wolfe said the FDA needs to quickly alert the public about
device recalls, noting that FDA announcements reach a broader
segment of the population than company announcements.
"There shouldn't be any hesitation about a public health
announcement," Wolfe said. Wolfe also serves on the FDA's Drug
Safety and Risk Management Advisory Committee.
DeLancy said that companies notify the agency when it starts
recalling devices. Companies then send a letter to customers
informing them of a recall and instructing them to either return a
device for a replacement, for example, or in many cases allowing
company representatives to fix a problem device in the field.
DeLancy said the agency then has to go through a process of
classifying the recall, which can take a few weeks. "The recall
happens immediately," she said. "The classification system doesn't
stop the recall."
Finally, Wolfe highlighted another recall announced this week
involving 14,000 automated external defibrillators made by Welch
Allyn, which the company started recalling last month. The company
said there's a "remote" chance that the devices could shut down
expectedly or deliver too low of an energy shock that's used to
jump start a person's heart.
The company said it received 20 reported instances of low energy
shock, eight of electromagnetic noise interference, and 11 of
unexpected device shutdown. Among the reports, two people died.
Welch Allyn has had at least five other recalls involving some of
its defibrillators since 2005, according to information about past
recalls posted on FDA's Web site.
But as of Friday there was no mention of the most recent Welch
Allyn recall on the agency's Web site.
In a separate letter to the FDA, Wolfe said, "This recall is
particularly alarming given it is the latest in a series of recalls
of defective Welch Allyn AEDs." He said the FDA needs to take "more
definitive action to end the use of these all-too-often defective
Welch Allyn devices."
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com