Medical Device Daily Washington Editor

A 13-page warning letter to International Technidyne (IT; Piscataway, New Jersey) gives an inside look at the operations at the subsidiary of Thoratec (Pleasanton, California) that had a lot to do with the recall of almost 6,000 ProTime blood coagulation monitors. (Thoratec in November estimated that the monitor recall would cost the company as much as $1 million but that the event would not materially affect it final financial guidance for FY07.)

One of the warning letter citations noted that IT received 864 ProTime units from a contract manufacturer that were not reworked to specifications for motor cradle modification. IT failed to generate non-conforming material reports for these units and distributed 858 of them.

However, FDA said, "your firm changed the device's specifications to a height of [redacted] in order to release reworked nonconforming product." The validation report for the change indicated that the altered height "caused a side force and resulted in a significant radial force applied to the pump assembly motor, which, over time, could cause the motor to slow down or fail."

The firm's first proposed fix for this "allows nonconforming product that does not meet specifications to be released based on a consensus decision made by your material review board," rather than by predetermined specifications, according to the letter.

FDA concluded that IT's process for disposition of non-conforming product was ""not adequately controlled."

The third citation stated that an unspecified number of ProTime units out of 160 "had non-conformances related to instrument errors for the 6.5 month period from July 20, 2006, through February 7, 2007" and that IT "did not initiate any formal CAPA [corrective and preventive action] until after the FDA investigator's review of an increase in non-conformances."

This citation also noted that two draft CAPA documents "are incomplete because they do not define the time points at which the quality data sources and trend analysis will be initiated" and because the procedures did not establish alert or action limits for non-conformances.

FDA deemed the company's responses to these findings inadequate because "they do not address corrective and preventive actions" for non-conformances and because the procedures did not require that the root cause of the non-conformances be addressed within three months.

IT did not return calls for comment.

A Nov. 16 warning letter to GE Healthcare (Waukesha, Wisconsin) addressed the installation for two of the company's X-ray systems in the jurisdiction of the agency's New Orleans district office. According to the letter, a field test of the systems revealed that X-ray production "was possible when the primary protective barrier was not in position to intercept the X-ray beam as required" by regulations. FDA recommended that the company correct the problem by repairing or replacing the unit "at no charge to the user" or if the problem was "caused by the factory-based manufacturer," to let FDA know by sending appropriate documents.

Brian McKaig, director of public relations for the company, said in a statement that "GE's initial investigation shows that the company's service personnel addressed the issue noted with these two devices soon after the FDA field test." McKaig also said: GE "takes the FDA test finding and warning letter very seriously and we are thoroughly investigating the matter."

A Nov. 29 warning letter addressed to E Med Future (Millersburg, Ohio) suggests the company's lack of familiarity with device regulations, listing nine deviations from good manufacturing practices and describing a company response to the inspectional findings as inadequate in five of them.

E Med manufactures the NeedleZap, a device that employs heat to destroy injection needles in hospitals and other clinical settings.

The first citation was that E Med had implemented no quality procedures, "effectively operating without any quality system." FDA gave no details as to the company's proposed remedy, saying only that the response appeared adequate and that the correction would be checked in a subsequent inspection.

The letter also cited a series of problems with the NeedleZap. According to the letter, "your firm has been reworking approximately 15% of the NeedleZap devices received from your contract manufacturer because of an issue with posts that were cracking in the NeedleZap case." Other units were returned to E Med due to various problems, such as lack of electrical charge, bad batteries and residual "needle waste."

FDA said that the company failed to determine the sources of these problems and did not trend or analyze any data in connection with the failures. The firm's response to this item was deemed inadequate due to lack of information on the statistical methodology E Med intended to use to analyze the data. Other citations include those for lack of procedures for testing equipment calibration and lack of quality audits.

Don Sullivan, the acting CEO of E Med, told Medical Device Daily "we've responded to the warning letter and we believe we are now in compliance." He termed the violations a matter of "paper compliance" rather than procedural compliance, adding: "we anticipate [FDA] will accept" the company's corrections.

A Nov. 28 warning letter to Precision Biometrics (San Carlos, California) addressed the firm's violative marketing of the MyoVision 8000 series of electromyographs, devices designed to detect the contractile state of muscle tissue. The letter said that a 510(k) clearance permitted the maker to market the device as a biofeedback device.

An October 2007 FDA review of the firm's web site disclosed that Precision had recently been marketing the device as diagnosing vertebral subluxations, but FDA said this usage was not approved and rendered the device adulterated. FDA also deemed the devices misbranded "because you did not notify the agency of your intent to introduce them into commercial distribution for the new intended use."