Medical Device Daily Washington Editor

The Obama administration finally has a full cabinet, thanks to the Tuesday Senate vote that came in at 65-31 to confirm Gov. Kathleen Sebelius (D-Kansas) to the position of Secretary of Health and Human Services, but the White House scored again when Sen. Arlen Specter (D-Pennsylvania) checked his GOP card at the door and defected to the Democratic Party.

The Sebelius nomination has been in the works for weeks following the departure of former South Dakota Senator Tom Daschle, whose bid for the HHS job tanked upon disclosure of unpaid taxes and conspicuously large fees earned by companies in the healthcare business. Sebelius' bid was troubled by both tax hangups and larger-than-reported campaign financing from late-term abortionist George Tiller, MD, but she nonetheless drew support from a number of Republicans, including ardent pro-lifer and fellow Kansan Senator Sam Brownback (R-Kansas). According to a report filed by the Associated Press, nine members of the GOP crossed party lines in her support, but no Democrats crossed over to oppose her.

Running in virtual parallel, Specter's defection was a 99-day gift to the Obama administration and a boon to congressional Democrats, but the move was not entirely unexpected. Democrats are said to have been wooing the centrist Republican for several years, and Specter faced a primary challenge from Patrick Toomey, formerly a member of the U.S. House from Pennsylvania and most recently president of the Club for Growth, a conservative political action committee. Many observers felt that Specter would likely lose to Toomey, in part because of Specter's vote for the $787 stimulus package earlier this year, and in part due to shifting political sentiments in the Keystone State.

Specter's move may give the party a virtual lock against a GOP filibuster on climate change and healthcare reform, but Maine's two Republican senators, Olympia Snowe and Susan Collins, are both known to vote across party lines, hence a filibuster was never seen as likely to succeed without help from Senate Democrats.

St. Jude warning cites validation hangs

St. Jude Medical (St. Paul, Minnesota) announced last week that it had received a warning letter from FDA while discussing its first-quarter financial results, which were that net income was up 14% over the same quarter last year. FDA finally got around to posting the warning letter at its web site Tuesday, and the heavily redacted warning letter depicts a less than exhaustive effort to establish a full set of validation procedures for the manufacture of the Safire ablation catheters for atrial fibrillation. However, FDA is concerned enough about the findings that the warning letter indicated that a follow-up inspection is in the offing.

The first finding dealt with what FDA said was a failure to validate a process that was redacted from the letter, but the agency notes that there was "no documentation to establish equivalence between other similar products/processes that had been validated. The finding is suggestive of a group validation strategy at the firm's Minnetonka, Minnesota plant, and while the agency has demonstrated in the past that it is amenable to group validation, St. Jude evidently failed to tie things together adequately.

The second finding also dealt with validation, but may or may not be related to the first. According to FDA, the company's validation for an electrical testing system did not demonstrate that the testing equipment was "capable of consistently and accurately identifying problems with catheter wires."

The warning letter detailed a problem with corrective and preventive action (CAPA) procedures that suggested that the company's quality control department had not exhaustively tied down all its loose ends. According to FDA, one of the company's CAPA procedures made reference to a risk assessment procedure that "had not been established." The warning letter offered no further detail on this finding. The warning letter also noted a citation for environmental monitoring in connection with the use of gloves in a controlled environment and one for lack of supporting data for sampling of in-process units.

The company declined to comment directly to Medical Device Daily, but Dan Starks, St. Jude's President/CEO, said during a conference call last week that the warning letter "doesn't affect any product roll-outs" and that the letter "relates to a documentation issue."

Maker of electrotherapy units strikes out

When a baseball team goes zero-for-nine, it means the inning is over. In the April 14 warning letter to Amrex Zetron (Carson, California), FDA's Los Angeles district office pitched one inning of no-hit baseball, citing the firm for nine citations and informing the firm that the agency didn't care for the company's responses to any of them.

The maker of various electrotherapy devices was cited for lack of a 510(k) or a PMA for a device which FDA did not identify. As for problems with the firm's adherence to the quality systems regulations (QSR), the warning letter led with a citation stating that Amrex's complaint-handling procedures "include inadequate procedures for complaint handling," but offered no details other than to state that the firm's response, "dated Nov. 17, 2009 is not adequate."

Later in the warning letter are indications that the problems are systemic. One citation notes that the company has not "conducted a management review in the past six years," and another that the quality system, while documented, had not been approved. A following citation states that an ISO quality manual dated May 2004 "has not been approved or released" and that "six of nine employees' training records show employees have not been trained on the quality policy." FDA also cited the company for lack of a written procedure for medical device reports (MDR) and for lack of procedures for testing equipment calibration.

George Bell, the company's president, told MDD there were "a number of things that were misunderstood" by the FDA investigator. He said that the 510(k) citation was due to an oversight with regard to re-registering the device and that the MDR finding was due to a lawsuit over a purportedly defective unit. "We couldn't identify the product and couldn't access the product because it had been lost in Hurricane Katrina," he said.

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