A Medical Device Daily

Food safety issues are among the foremost on FDA's agenda, and the peanut butter salmonella outbreak has pushed Rep. Rosa DeLauro (D-Connecticut) into proposing a bill that would create a new agency that would over see food safety. DeLauro announced the move in a press conference held Wednesday, during which she pointed out that some food products are liable to fall into a crack between FDA and the Department of Agriculture, both of which exercise some jurisdiction over food.

DeLauro was quoted as having said,"There is no one single individual to be held accountable for food safety at the FDA" or at any other of the agencies under the Health and Human Services umbrella. DeLauro chairs the House Appropriations Committee's agriculture subcommittee, which sets the House's proposed FDA budget.

According to a transcript of the press briefing provided by Congressional Quarterly, DeLauro said that her bill, the Food Safety Modernization Act of 2009, would"separate food safety regulation from drug and device approvals and to restore, in my view, the balance that has been long missing at the Department of Health and Human Services." The bill, which runs parallel to a bill by the same title introduced to the 110th Congress last year,"would establish a food safety administration ... headed by its own commissioner, allowing food safety experts and researchers to do their job."

DeLauro acknowledged that"there are good people and good science at the FDA," but she nonetheless made the case that Americans"need an agency that's fully committed to actively preventing food-borne illness, not just reacting to it. This is about prevention." The bill would also mandate routine inspections and require that foods be traceable. She pointed out that while"these are not new ideas, the push for change could not be more urgent."

While DeLauro's committee is not in a position to put the legislation on the House floor, she said that the chairman of the Energy and Commerce Committee, Rep. Henry Waxman (D-California), is"open" to the idea.

I-Flow warning, suits, belie Frost award

Some warning letters are just letters whereas others are more like dissertations. The Dec. 22 warning letter to infusion pump maker I-Flow (Lake Forest, California), suggested a primer on the quality systems regulations (QSR), running 19 pages when printed out as a PDF document. However, the letter may be the least of the firm's troubles going into 2009.

Wire service reports indicate that I-Flow won the 2009 Growth Strategy Leadership award by Frost & Sullivan (San Antonio) for the success of the firm's On-Q pain relief system on Jan. 13, after the date of the warning, but before the agency posted the warning letter this past Tuesday.

I-Flow also faces a number of lawsuits by patients in Arizona who allege that the treatment of shoulders with anesthetics delivered via the On-Q resulted in deterioration of cartilage in the shoulder. The aggregate sum being sought in those suits is pegged at $68 million.

The agency found that I-Flow's response to each of the 18 inspectional findings cited in the warning letter was either inadequate or could not be confirmed. This was not for lack of time, however, as FDA indicated that the inspection took place between March and May 2008 and that I-Flow had sent the agency at least three letters dealing with the situation, the latest of which was dated Aug. 22, 2008.

FDA led with a citation that noted that the company had procedures in place for device design verification with testing for finished devices, but failed to follow those procedures for several devices. In one instance, the qualification report for one infusion pump employed a catheter other than was called for in company procedures, which led to a failing result. The heavily redacted warning letter also noted several instances in which a weld failed, leading to problems with flow rates. FDA did not detail the firm's responses to this series of findings, but stated that the responses"are inadequate because you have not fully implemented procedures for verifying device design."

Under a citation for corrective and preventive action (CAPA), FDA says"a report was opened for the incomplete weld housing" in reference to a weld used to join the two halves of the housing for a large-volume, patient-controlled analgesic (LVPCA) activation button. The firm had received complaints that the activation button had become stuck, which was addressed in part by manufacturing the two halves of the housing with beveled edges known as chamfers. I-Flow had tested the fix by pressing the bolus button on the re-engineered units fewer times than procedures mandated, leading to part of the CAPA citation, which also noted problems with adjustments the firm made to other components of the activation button assembly.

The warning letter says that the documentation offered I-Flow describing the corrections for these citations does not clearly demonstrate that the problems"have been verified, validated, shown to be effective and that they do not adversely affect the device." FDA further said that the documents"are drafts or are incomplete.

The inspection also apparently disclosed that I-Flow's validation reports for the shelf life of several components of infusion pumps did not include details such as storage conditions, start and end dates of the validation study, and equipment used in shelf life studies. Perhaps even more damaging was a citation that states that"no post-market surveillance reviews were performed using data after year 2003 as required" by company procedures. The firm's response to this finding flunked because"you have not fully implemented these procedures."

At press time, I-Flow had not responded to phone and e-mail requests for comment.

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