A Medical Device DailyFDA announced Wednesday that it is elevating the recall of the Colleague line of infusion pumps, made by Baxter Healthcare (Deerfield, Illinois) to a class I recall scant weeks after the initial recall announcement in January. Neither this nor the previous recall announcement requires that the devices be pulled from the market, but according to a statement at the Baxter web site, "safe and effective use of Colleague pumps is dependent on specific battery care practices as described in the operator's manual."
Baxter is not alone among infusion pump makers who have made the news of late. I-Flow (Lake Forest, California) found itself with an FDA warning letter in December thanks to inspectional findings that filled out a very unusually long, 19-page warning letter (Medical Device Daily, Feb. 6, 2009), and Cardinal Health (Dublin, Ohio) recently amended the terms of an FDA consent decree it has been working under since 2007 in connection with its infusion pumps to include all of its line of "303" pumps because of violations of good manufacturing practices.
The announcement of the Baxter recall updates a Jan. 23 announcement of a field correction, with the latest recall indicating a risk of serious injury or death in connection with the pumps' use. According to the FDA announcement, the action affects six models of single-channel and triple-channel volumetric pumps. According to the March 11 announcement at the Baxter web site, the latest recall is "based on findings from [Baxter's] ongoing quality control processes," and the firm acknowledged that "there have been serious injuries and/or deaths associated with failures identified in this letter."
FDA also announced on Monday a class I recall for a cuffless pediatric tracheostomy tube made by Covidien (Mansfield, Massachusetts) because of reports of difficulty placing the tube. The initial alert dated Jan. 14 informed purchasers of the problem, and the March 9 notification withdraws all units. According to a company statement, "a patient required additional medical intervention and respiratory support, prior to being returned to a ventilator" in one instance.
Netherlands reboots Petten reactor
Global supplies of technetium-99 (Tc99), a radioisotope with a half-life of about six hours, have been problematic of late because suppliers in at least two nations have announced suspensions of production of the medical-grade isotope for varying reasons. The good news last month coming out of Petten, the Netherlands, however, is that a reactor operated there by the Nuclear Research and Consultancy Group (NRCG) will resume processing of molybdenum-99 into Tc99.
According to an article in the Feb. 16 edition of Your Nuclear News, NRCG has opted to reboot the reactor despite the fact that technicians have not restored coolant pipes in the reactor to the desired thickness, which are said to have thinned to as little as 3 millimeters in some spots "from an original design thickness of 9.5mm." The article states, though, that the facility has experienced no loss in cooling function since the discovery in 2005 of the degradation of pipe thickness,
Because of an unspecified development, the article states that "a new shortage situation arose" on Feb. 9 that left Europe with no capacity to produce Tc99. The Dutch government requested that NRCG restart the reactor, which the operators of the facility agreed to do until March 2010 contingent on tighter thresholds for operating limits.
NRCG announced the shut-down last year (Medical Device Daily, Sept. 17, 2008), which put more pressure on the supply chain despite the recommencement of processing in December in a plant in Canada that Atomic Energy of Canada (AEC; Mississauga, Ontario) had shut down the previous month. AEC had started work on another reactor to process uranium into the precursor of Tc99, molybdenum-99, but cost overruns compelled the firm to abandon the effort.
While the news is welcome, a Feb. 12 statement at the web site for NRCG throws a blanket of caution on the news. The statement notes that if "any abnormalities are identified, then NRCG will follow its standard procedures and immediately stop reactor operations." On the other hand, NRCG intends to "replace the relevant sections of the primary cooling water system in 2010." The statement also notes that the reactor in Petten "produces 60% of the European and 30% of the world demand for medical isotopes."
FDA commish rumor mill in high gear
At press time yesterday, the Obama administration was mum on the question of whom it would nominate for the position of FDA commissioner, but the Internet was abuzz with speculation. Wire service reports state that the White House is eying former New York City health commissioner Margaret Hamburg, MD, for the head spot, but also has her deputy commissioner picked out in the person of another rumor-mill personality, Baltimore health commissioner Joshua Sharfstein, MD.
Sharfstein is seen as a favorite for some appointment or other in part because he is on the administration's vetting team for the FDA post, but he also served as a staffer for Rep. Pete Stark, chairman of the House Ways and Means health subcommittee. Hamburg's resume includes a six-year stint as the commissioner of public health for New York City and served as the assistant secretary for planning and evaluation at the Department of Health and Human Services during the Clinton administration.
In a Thursday statement, Stephen Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said the association "welcomes the nominations of Dr. Hamburg and Dr. Sharfstein to lead this crucial government agency." Ubl also said "[t]heir records of leadership will help ensure FDA will continue to fulfill its vital mission of protecting and promoting the U.S. public health."