Medical Device Daily Washington Editor

The Aug. 25 warning letter to breast pump maker Evenflo (Miamisburg, Ohio) contained a fairly routine list of deviations from the quality systems regulations, but one of the more unusual citations was for failure to validate changes to the firm's document control procedures for documents that are externally generated. However, the warning letter does not indicate that Evenflo has any contract manufacturing arrangements that might explain the finding and, in any event, the citation is possibly unique among warning letters published over the past few years.

The firm responded to the inspectional findings with five letters, which were sent to the agency between March and July, managing to successfully deal with several of the findings listed in the warning letter, but the agency indicated it is not happy with all the proposed corrections.

The January-February inspection of Evenflo's plants in Miamisburg and Piqua, Ohio, led to a citation for both plants for failure to document the rationale for not investigating 18 complaints. Among these was one in which breast milk had leaked "out of the electrical adapter port and caused an electrical shock," and another customer was said to have been shocked when plugging the unit into an outlet. In the third listed complaint, all of which were from 2007, a customer stated that she was shocked while using the pump, that milk "came out of the motor housing," and that the pump exerted inconsistent vacuum pressure.

Without providing any further detail, FDA notes that the company's response to this finding was adequate.

The citation for failure to validate the document controls pertained only to the Miamisburg plant, which was also the case for the remainder of the citations. FDA provided no detail for this finding, listing it along with two other corrective and preventive action (CAPA) validation failures.

One of the other two CAPA citations dealt with the electrical shock problem, which the firm is said to have addressed by adding a rib to an overflow valve in an effort "to prevent milk from overflowing and causing problems with the pump." FDA states that the relevant corrective action "did not extend to ... devices which you sold prior to December 2008," and FDA asserted that the verification of those corrective actions "failed to justify" the omission.

The warning letter notes the company released a design into production for single and dual pumps in October 2008 but according to the warning letter, "the drawings were not approved for release by all parties until January 8, 2009." FDA provided no further details other than to state that the proposed correction, which was not described, was adequate.

A citation regarding quality audits for Evenflo's CAPA system states that the company had claimed that it had conducted such an audit in October 2008, but that the relevant documents "could not be found."

FDA states later in this citation that the company had also said that "the audit had not been performed and that there was a documentation error." The agency was apparently dissatisfied with the company's response to this finding because the proposed corrections do not make clear "how these changes will prevent you from failing to perform future audits." The agency indicated that it will take this matter up again in a future inspection.

Evenflo was said to have lacked procedures for medical device reports (MDRs), and the firm's response was deemed inadequate for several reasons. One was that the new procedures did not describe how the company will "submit initial, supplemental, or 5-day reports to the FDA within the timeframes required" or how Evenflo will "conduct an investigation of each event, evaluate the cause of the event, and submit complete reports."

According to the warning letter, Evenflo had conducted a clinical investigation into a breast pump redesign commencing in May 2008 without notifying the agency. The firm's initial response to this citation was that Evenflo was of the view that the study "was not for the purpose of determining safety or effectiveness," and that when added to the fact that the pump is deemed a non-significant risk device, the company was not required to inform the agency of the study.

FDA's view is that because one of the stated purposes of the study was to "determine the effectiveness of the modified pump," the study was not exempt from such requirements. That determination led to citations for failure to list the study with an institutional review board and failure to obtain informed consent from subjects. The device in question, the Comfort Select pump, was the object of an intended modification to a 510(k) filing.

In an unattributed statement e-mailed to Medical Device Daily, Evenflo states that it has been "working in cooperation with the FDA for several months to address the FDA's observations," an effort that includes "several updates – including supplementary documentation and information on how the company is enhancing its internal written procedures."

The statement indicates that FDA had informed the company in August "that that several matters remain open," but that Evenflo "expects to respond to the FDA's recent letter within the next week and is confident that we will be able to resolve these matters."

Franken comes to device makers' defense

As a comic, Sen. Al Franken (D-Minnesota) could hardly be described as a supporter of Wall Street firms, but his election in a state with a strong presence in the medical device industry has prompted him to change his tune. In a Sept. 15 letter, Franken and four other senators indicated their concern that the device industry tax provisions in the healthcare reform bill written by the Senate Finance Committee would "seriously threaten thousands of American jobs and deter innovation."

The letter, which was also signed by Sens. Amy Klobuchar (D-Minnesota), Evan Bayh (D-Indiana) and Richard Lugar (R-Indiana) adds that the tax would translate into "an annual income tax surcharge of between 10-30%," which would dial down investment in new products.

The letter goes on to argue that industry will already be laboring under the healthcare reform proposals currently in play, which would trim Medicare spending and hence cut as much as $17 billion out of medical device revenues over 10 years. The senators "respectfully request[ed]" that Sen. Max Baucus, chairman of the Senate Finance Committee, reconsider "this provision as a part of the Finance Committee's proposal."

Mark McCarty, 703-268-5690;