Medical Device Daily Washington Editor

As anyone in the drug or diagnostics businesses knows, media fill rooms are sensitive places, and the Nov. 3 warning letter to Gibson Labs (St. Cloud, Minnesota) serves as a forceful reminder that FDA, too, is keenly aware of the need for sterility in such operations.

According to FDA, the firm's plant in Lexington, Kentucky, turned out 27 lots of various agars between 2008 and 2009 that had had been contaminated, and FDA cited the company's validation for media fill room cleaning as a sore spot. This citation stated that the use of sporicidin had not been validated for the fill room, although FDA does not state whether other sterilants had been validated for that purpose.

In any event, the warning letter states, "the fill room has had 14 days between January 2008-August 2008 and January 2009-July 2009 where environmental count plates were at or above your firm's action limits" for microbial counts "after this room had been fogged" with sporicidin.

The August-September 2009 inspection also disclosed that the 14 lots rejected at the Lexington plant in 2008 triggered a corrective action of employee retraining in aseptic technique, and FDA notes that the effort "was ineffective," given the 13 contaminated lots that followed this year. The warning letter asserts that Gibson's investigation into the failures in 2008 did not include "the results of environmental testing of the fill room for the days in which the contaminated product was produced," hence leading the agency to conclude that the firm had not established the root cause of the contamination. FDA also said that the employee retraining undertaken in response to the contaminations in 2008 was not documented.

The warning letter also states that Gibson had not validated the autoclave sterilization for the media, at least to the extent that the company could not justify "that the product loads used during" the validation "are the hardest to sterilize." This citation included no further detail for this finding, but this citation also notes that Gibson could not justify the use of only one temperature probe in the autoclave and could not document the rationale for using a sterilization run of less than a redacted number of minutes.

Gibson also found itself in hot water for the cleaning validation for media fill equipment. FDA states in the warning that the actual validation runs lasted for a duration other than that which was indicated in the firm's validation plan. The durations in question were again redacted. The firm is also alleged to have failed to develop procedures for medical device reports.

Gibson did not respond to contact for comment.

Firm: defib problems 'extremely remote'

FDA recently reported an upgrade of sorts of the field action alert issued Nov. 13 by Cardiac Science (Bothell, Washington) in that the alert "does not sufficiently describe the existing defect" in the firm's automated external defibrillators (AEDs), according to FDA. However, Cardiac Science has expressed the view that the agency's concerns are overblown and that the units are performing according to specifications.

Cardiac Science reported on Nov. 13 that it has "received a total of 64 complaints concerning four resistors" found in two lines of the company's AEDs. The affected units include seven models of the Powerheart and three models of the CardioVive, all manufactured between August 2003 and August 2009. According to the company's Nov. 13 statement, "two of these complaints were associated with a failure to deliver therapy" while another 114 complaints addressed "service required" messages the company said were the consequence of "a specific relay switch failure."

Cardiac Science also noted in the Nov. 13 statement that there were "no reported instances where this issue has resulted in an inability to deliver therapy," and that the problem is "predicted to occur in approximately one in 75,000 AEDs." The company intends to deliver a software fix in May 2010.

FDA's Nov. 19 statement says little more about its disagreement with the company other than to note that the agency is "concerned that the company's proposed actions do not adequately address the problem."

Cardiac Science shot back with a Nov. 20 statement posted at the firm's web site in which CEO Dave Marver said that the company has "worked closely with FDA throughout the last couple of months" and that FDA staffers are "responsibly performing their duty to protect public health."

Nonetheless, Marver said that while Cardiac Science "respect[s] and appreciate[s]" FDA's efforts," he is of the view that his company "has taken a very conservative approach throughout this process." He noted that the company "stopped shipping for five weeks this summer while we investigated and fixed the issue in production" and "also brought in several outside experts to assist us in determining an appropriate set of actions."

According to Marver, the list of experts includes "cardiologists, emergency medicine physicians, retired FDA professionals, and risk engineers," and he said that the company has "committed huge resources to implement a software update to further enhance the reliability of our AEDs in the field despite the very low probability a device would ever fail to deliver therapy." Marver added that the defibrillators "are performing within their design specifications and are by all measures extremely reliable."

Mark McCarty, 703-268-5690
mark.mccarty@ahcmedia.com