Medical Device Daily Washington Editor

Trends are part of the lives of FDA investigators, but some issues seem like soap opera sirens: years go by and faces change, but they still sound the same.

The Aug. 19 warning letter to AliMed (Dedham, Massachusetts), maker of a range of medical accessories, cites a number of deficiencies in the company's tracking and handling of complaints as well as failures to report adverse events as medical device reports (MDRs). In one instance, a patient using a seatbelt alarm made by AliMed fell and suffered a fractured hip, but the warning letter states that a consultant "determined that an MDR was not required for this event."

FDA led the warning letter with a citation for lack of procedures for corrective and preventive action, followed by a citation that states that the company conducted no investigation in connection with several complaints after those complaints were deemed to be "not of interest."

Among these was a December 2007 incident in which a pull-cord alarm, designed to alert caregivers when a patient leaves a bed, failed to sound on three occasions. A cushion with an embedded alarm, the Sit-Straight cushion, was the subject of a complaint the previous month due to a short in the alarm mechanism.

The warning letter cites the firm for "failure to report information that is reasonably known" to the company in reference to the pull-cord alarm and the Sit-Straight cushion, and while the agency refers to the portion of the Code of Federal Regulations that describes MDRs, the letter does not state specifically that these were failures to file MDRs. The agency also states that AliMed had no quality policy and no management review procedures. At press time, AliMed had not responded to a call for comment.

BioMedix warning also cited complaints

In the Oct. 18 warning letter to BioMedix Vascular (St. Paul, Minnesota), FDA led with a citation for lack of management attention to a quality system, immediately specifying that the issue was that "the system for complaint handling is not adequate." BioMedix makes the PADnet+, a cardiovascular blood flow monitoring system.

According to FDA, the inspection disclosed that "no investigation was conducted" for five complaints of inaccurate measurements and two complaints of "incorrect data storage." The company received total of five other complaints that were not investigated, including for irregular pressure recordings, cuffs that did not inflate, and failures to function.

FDA gave a laundry list of elements that the firm's corrective and preventive action procedures were said to have lacked with regard to the complaints noted. Among these were a timely completion of corrective and preventive action (CAPA) reports and presenting those reports to executive management. Other problems associated with CAPA work were "identifying appropriate corrective/preventive action to address root cause," and completion of "responsible person portion of" the CAPA report.

The warning letter cited BioMedix for failure to conduct quality audits at appropriate intervals, noting that the October 2007 audit was preceded by an audit conducted in December 2004, "which failed to meet the two-year audit frequency required" by regulations. FDA also informed the company that the brochure for the PADnet, which indicated the device is "FDA approved," caused the device to be misbranded because BioMedix acquired the agency's go-ahead for the device via a 510(k).

The warning letter states also that a response from the company's chief technology officer, Will Rogers, "discusses some corrective action, but fails to provide complete evidence that corrections have been made. FDA indicated it will check on corrections via a follow-up inspection, although the agency did not commit to a date.

John Roman, the company's CEO, told Medical Device Daily that the inspection gave the firm a chance to tighten things up. "We think the recommendations improve our compliance program," he said. The company's compliance difficulties stem in part from the fact that "the company has been growing rapidly," Roman said, creating a need for additional quality control staff. He also noted that BioMedix has retained outside help to get things back in order. "We've hired an outside consultant and a certified auditor" to get the company's compliance efforts up to speed.

C Change warning cites design controls

The Sept. 24 warning letter to C Change Surgical (Winston-Salem, North Carolina) listed no complaint handling issues, but deals with the firm's changes to the design of its Intratemp solution warmer for surgical fluids. By FDA's reckoning, those changes were of sufficient importance for FDA to deem the product adulterated.

The first citation says that the firm's design history documentation omits information on "design/development changes as they occurred during the design process" for the Intratemp. Among the changes cited in the warning letter, issued in connection with an inspection conducted in March, are "hazard warning statements, electrical specifications and assembly housing." The agency says that the company's response did not suffice because it "discusses your intent to organize the design history file but does not address changes to the device without supporting documentation."

FDA also cited the company for failure to ensure that device design outputs met design requirements, but went into no detail on the specifics of the finding or the company's response.

The agency cited C Change for lack of complete specifications for accepting or rejecting Intratemp units in reference to burn-in temperatures, which are "intended to identify premature component failures." FDA's response to the company's proposed fix was that the temperature ranges are acceptable and that the agency would confirm those changes upon the next inspection.

The agency states that in its view, "the design changes ... could significantly affect the safety or effectiveness of the device and therefore constitute significant changes or modifications that require a new 510 (k) submission." The letter states that the changes include a component – the identity of which was redacted – that was added "due to reports of current leakage," as well as a change of a fuse. The company is also said to have added a "controlled temperature feature" to the Intratemp, and out of range temperature lights are said to have been modified.

Patrick Kammer, the firm's CEO, told MDD only that "the problems have been resolved and we have requested reinspection." He could not say when FDA might schedule another inspection of the company's plant.