Medical Device Daily Washington Editor

Makers of infusion pumps have been locked into FDA's regulatory cross-hairs for a number of months, and the agency released a recent statement adding WalkMed Infusion (Englewood, Colorado) to the list.

According to the Nov. 24 FDA statement, the announcement last week served as "an update to a previously announced recall" of the Triton pole-mounted infusion pumps, which was undertaken because "the pump door open alarm does not always work on all pumps to alert the user that the pump door is open." FDA states that in such a state of affairs, the pump might still have operated, thus potentially resulting in "free-flow perfusion," which could cause serious injury or death, making the recall a class I recall.

WalkMed is refurbishing the Triton pumps, but consumers who cannot get their unit swapped out for a refurbished unit are advised to ensure that the pump door "is completely closed and latched prior to use by tugging on the pump door and follow the instructions in the operator manual to check that there is no flow through the tube set before starting the pump." The recall affects units manufactured up until June. FDA states that the recall is voluntary and that "no injuries have been reported to date and no reports of this issue have been received from field use." The agency adds that the problem has affected about "40% of pumps tested," although the agency did not specify that the company had conducted the tests.

The recall of the Triton is another in a series of infusion pump recalls undertaken either voluntarily or at the agency's behest. Sigma (Medina, New York) had contracted with Baxter Healthcare (Deerfield, Illinois) to provide the former's line of Spectrum infusion pumps to replace Baxter's Colleague recalled line of pumps earlier this year, but FDA announced a recall of Sigma units earlier this month (Medical Device Daily, Nov. 17, 2010). The emphasis on infusion pumps is part of the greater push for patient safety at FDA's Center for Devices and Radiological Health, which has tackled device classes as disparate as automated external defibrillators and radiological imaging and therapy equipment toward this end.

WalkMed did not respond to contacts for comment.

Advanced pulls HiRes hearing aids

Advanced Bionics (AB; Valencia, California) announced last week a recall of the firm's HiRes 90K cochlear implant device in all nations. According to the Nov. 23 statement by AB, the device "will be removed from the market as a precaution while the company works with" FDA "to address the issue."

AB states that it is aware of two instances in which "the product experienced a rare malfunction requiring explantation." The malfunction is said to have caused patients "severe pain [and] overly loud sounds and/or shocking sensations at 8-10 days after initial activation" of the device. The company states that it is working with FDA "to identify the problem and institute changes to the product to ensure" the HiRes 90K will work as advertised. The firm's parent company, Sonova Group (Stafa, Switzerland), said in the statement that it cannot yet "predict the impact the recall will have on sales and operating income for the remainder of the fiscal year" for Advanced Bionics, but that as soon as officials at Sonova are "able to ascertain the fiscal impact of the recall, it will communicate this information."

AB did not return contacts for comment.

FDA updates 1990 IVD/clostridium guidance

FDA has produced an updated version of a guidance with 20 years of life under its belt, although yesterday's Federal Register notice states that the guidance is not in force and, as seemingly always, "not final at this time."

The guidance deals with in vitro diagnostics for the bacterium Clostridium difficile, associated with disorders of the lower gastrointestinal tract, and the agency describes the new guidance as "a revision of" the May 31, 1990 guidance titled "Review Criteria for Assessment of Laboratory Tests Directed at Assisting in the Diagnosis of C. difficile Associated Disease." FDA says in the guidance document that it has updated the guidance "to include new issues and technologies identified since the 1990 guidance," such as the use of real-time polymerase chain reaction tests for nucleic acids associated with C. difficile.

The scope of the guidance is restricted to "the devices described in existing classifications," the guidance document says, but "may be applicable to other ... diagnostic devices that do not fall within these existing classifications." Among the other devices that could be captured by the guidance are any de novo diagnostics applications "as well as subsequent devices that seek determinations of substantial equivalence to future de novo cleared devices."

FDA ponders reclassification of ECT devices

FDA may seem to industry to be on the warpath, but the agency has had a few carrots to offer along with the sticks. The agency reported yesterday in the Federal Register that it will hold a two-day session in January to obtain an advisory committee's views on reclassification of devices used in electroconvulsive therapy, or ECT.

According to the FR notice, the meeting will take place Jan. 27 and 28 at the Hilton Washington DC North Hotel in Gaithersburg, Maryland, and the agency expects the neurological devices advisory committee to be in session from 8 am until 6 pm both days. Those interested in commenting for the docket may do so at www.regulations.gov by Jan. 26, and parties wishing to address the panel in writing or in person at the hearing are instructed to reach out to James Engles, (301-443-0572, james.engles@fda.hhs.gov).

House passes bill to patch SGR chasm

The physician fee schedule under Medicare Part B has been the subject of a game of double-dog dare by the U.S. Congress for several years now, with the occupants of Capitol Hill unwilling to let the scheduled cuts go through but unable to come up with a permanent fix for the problem. Just in the nick of time, Congress has once again cobbled together and passed a bill that would punt the issue into the future one more time, this time in the form of H.R. 5712, also known as the Physician Payment and Therapy Relief Act of 2010.

The bill, which is effective until Dec. 31, passed the House of Representatives yesterday after sailing through the Senate on Nov. 18. The legislation wards off cuts of 23% to physician fees under the sustainable growth rate (SGR) mechanism, cuts which many physicians claim would force them out of the business of providing for Medicare patients. This is not the first time Congress has danced close to the edge of the cliff and beyond where SGR is concerned. On at least one occasion, previous patches to SGR had expired, although the Centers for Medicare & Medicaid Services typically held up payments until Capitol Hill came through with an SGR override.

However, one medical specialty society, the American College of Cardiology (ACC; Washington) saw fit to sue the Department of Health and Human Services over the proposed cuts, essentially arguing that the fee structure for cardiology care would be based on "an invalid physician practice information survey" (Medical Device Daily, Dec. 31, 2009).

Mark McCarty, 703-268-5690

mark.mccarty@ahcmedia.com

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