Medical Device Daily Washington Editor

Heavy redaction of warning letters makes for uncertain interpretation, but the Sept. 10 warning letter to Baxter Healthcare (Deerfield, Illinois) points clearly to an oncology product made at the firm's plant in Halle, Germany, operating under the name of Baxter Oncology. According to FDA, Baxter's oncology product, the name of which is redacted throughout the warning letter, is misbranded because of two changes in chemical components of the device. However, the most damaging aspect of the situation in the agency's eyes may be that one of those changes came into being 10 years ago.

A Baxter spokeswoman confirmed to Medical Device Daily that the device in question is the Isolex, a unit described on the firms' web site as indicated "for processing autologous peripheral blood progenitor cells (PBPC)" in pursuit of "hematopoietic reconstitution after myeloablative therapy in patients with CD34-negative tumors."

According to the warning letter, FDA inspected a series of plants operated by Baxter, starting with the Deerfield plant in April and subsequently extending in June to three plants in California, including one in Los Angeles, as well as the Halle plant. Baxter offered six responses to the inspectional findings, but they apparently availed the firm of nothing as the warning letter suggests.

The warning letter commences with the misbranding citation, a finding that keys on the discover that components of the device are not "suspended in phosphate buffered saline" under a monograph by the U.S. Pharmacopeia (USP) as indicated in the product's label. The agency asserts that this state of affairs has persisted "since 1999." Linked to this finding is a citation that the device is adulterated because "its strength, differs from or its purity or quality falls below that which it purports or is represented to possess." No other citations expressly address the phosphate buffered saline unless redaction has eliminated such discussions.

However, this finding is apparently the trigger for a citation alleging that Baxter had neither investigated nor followed up on "potential causes of low yield and/or low purity performance issues for the [redacted] product." The warning letter states "further investigations ... were identified as proposed initiatives in March 2008."

Another finding that helped feed the issuance of the warning letter was that controls for incoming product failed to specify a source of albumin and did not establish "that the [redacted] used to manufacture beads for the U.S. market must meet USP and license requirements." The warning letter states further in this citation that the beads "are received by the Baxter facility in Van Nuys, California, and released by" the Los Angeles plant. However, FDA does not explicitly state that the albumin and/or beads were used in the Isolex.

Another citation, one dealing with controls for design changes, mentions albumin in the context of a consolidation of an unspecified number of part numbers "into a single part number via change notice" for the product label. According to the warning letter, the use of the single part number "does not enable distinction between the U.S.-licensed albumin" made in the firm's Los Angeles plant, said to meet USP requirements, and albumin "manufactured by your Vienna facility, which meets EP (European Pharmacopeia) requirements."

Mavis Prall, Baxter's director of scientific communications told MDD that the firm "has corrected the supplier-related issue" which was predicated on the fact that "the supplier used EU-sourced plasma in the regent kit and not U.S.-sourced plasma as indicated in the label." She also notes "it was Baxter that identified and voluntarily reported the issue to FDA."

Baxter is working with FDA "to address the other issues outlined in the observations," Prall also said.

Agency reclassifies wound dressing

It's not often that industry feels like it scores with FDA, but the recent announcement – that the agency will allow wound dressing with an additive described as poly-diallyl-dimethyl ammonium chloride (pDADMAC) to be reclassified as a class II device, subject to special controls is a small but heartening win for industry.

According to the Oct. 16 announcement, FDA's guidance on the move "is being immediately implemented ... but it remains subject to comment in accordance with the agency's good guidance practices."

FDA, which is accepting both snail-mailed and electronically submitted comments, says that it "will consider any comments that are received in response to this notice to determine whether to amend the guidance document," essentially setting no deadline for comment.

FDA eyes imaging for biopsy samples

FDA will hold later this week a two-day meeting to address "the use of digital whole slide imaging systems to replace conventional light microscopy for diagnostic surgical pathology." The meeting of the hematology and pathology devices advisory committee will take place Oct. 22 and 23 at the Hilton Washington Hotel in Gaithersburg, Maryland. The announcement states that the committee will also address how this technology conveys images on computer monitors in diagnostic work-ups as well as digital imaging archiving systems, but "will not be discussing computer-assisted image analysis or remote real-time microscopy."

FDA following up on power cable issues

The Aug. 12 warning letter to Hospira (Morgan Hills, California) dealt largely with power cords provided with some of the firm's infusion pumps, but the fact that Hospira did not make the cables nonetheless left it liable in the agency's view. However, FDA has announced that it is looking further into the situation.

In an Oct. 19 statement, the agency said it is "investigating whether certain types of power cords used with medical devices may be defective. The statement notes that both Hospira and Abbott Nutrition (Abbott Park, Illinois) have filed reports in connection with "reports of sparking, charring, and fires from the power cords used with their devices."

The reports, which are said to total 122, all involve cables manufactured by Electri-Cord (Westfield, Pennsylvania). The agency notes that the cords are in use for equipment made by other manufacturers and that FDA "is now attempting to determine which devices may be equipped with these cords." The statement also notes that providers should keep a close eye on damaged cords, stating that such vigilance "is especially important in oxygen rich environments."

Mark McCarty, 703-268-5690