Medical Device Daily Washington Editor
An Jan. 20 warning letter to Nidek Medical (Birmingham, Alabama) deals primarily with medical device reports (MDRs), which have proven to be the bane of a number of device makers of late. Perhaps the most noteworthy item in the warning letter, however, is that FDA cites the company for a 510(k) violation over the fact that Nidek switched out a device component to render the device identical to a previously cleared iteration.
The first citation dealt with evaluation of complaints in terms of whether to file an MDR. FDA writes that Nidek did not document its evaluation of a complaint from December 2006 in which capacitors failed in two different models of oxygen concentrators. In one incident, the patient complained of "smoke coming out of the device," and the warning letter notes further that another complaint for which the firm lacked documentation of its evaluation involved the use of an incorrect voltage meter in an oxygen concentrator, which led to a "burn."
The company's response failed to include a copy of the form to be used to document complaint evaluations and FDA requested a copy.
The warning letter also notes a December 2007 incident in which a patient expired while on one of the firm's oxygen concentrators. The complaint involved an alarm that failed due to an unspecified part that depleted a battery as well as a lack of oxygen flow caused by a bad pipe fitting. Nidek is said not to have filed the report because "the device did not cause or contribute to the patient's death" and because the device is intended as "a life-enhancing device rather than a device intended to be life sustaining." FDA notes that the firm's interpretation of events and purposes did not relieve it of responsibility for filing an MDR.
FDA asserted that a change to the oxygen concentrator for the Mark 5 unit called for a 510(k) filing, but redacted the passage describing the nature of the change to the unit's design. The warning letter also states that Nidek lacked clearance or approval for three models in the firm's Nuvo line of oxygen concentrators.
Regarding the MDR citation, Len Suelter, the company's VP for business development, told Medical Device Daily, "our biggest problem may be that we didn't have the sense to respond to the 483," but added that while the company had evaluated all adverse events, they had not documented those evaluations.
Suelter said the previous FDA inspection had taken place three years earlier and that the firm had undergone an ISO inspection in November, two months after the FDA inspection.
As for the 510(k) finding for the Mark 5, Suelter said the firm "had built a new model with a flow meter" in replacement of a fixed orifice, which was part of the previously cleared design. The firm got in trouble by bringing back the fixed orifice for a customer who specifically asked for it, and Nidek did not realize FDA would cite them for bringing back the previously cleared configuration.
Contract manufacturing banes persist
An Feb. 12 warning letter to Bass Medical (Birmingham, Alabama) hints at contract manufacturing problems, noting that the firm is the specification developer of the only product described on the company's web site, the Bass fluid control system, designed to corral the fluids that escape the surgical table during operations. Despite the fact that the inspection took place in September, FDA cites no responses to the 483, an indication that like Nidek, Bass offered no response.
Several of the citations were described by language that suggested gross deficiencies, including that Bass had "no quality systems procedures and instructions for your device" and that "there are no CAPA [corrective and preventive action] procedures for your device." FDA also noted that Bass had no procedures for verification of incoming products, including finished devices. Bass also apparently outsourced its complaint-handing work, but FDA cites the firm for failing to establish procedures "to ensure the regulatory requirements were met."
The warning letter highlights a fairly common but significant finding for companies that outsource production. FDA states that Bass had no agreement with the contract manufacturer, which was not identified in the warning letter, that required that the contractor inform Bass of any changes made to "the product or service" so as to allow Bass to evaluate such changes for potential impact on finished device quality.
Bass was also snared by the MDR fishnet, with FDA citing the firm for three violations. One states that Bass was unable at the time of the inspection to offer a copy of procedures for determining whether an event calls for an MDR, and the letter also cited the firm for procedures that did not lay out specific guidelines for "the timely completion and transmission of MDRs to FDA." The company had not responded to calls for comment by press time.
SSI hit for absence of basic GMPs
An Jan. 7 warning letter to surgical laser maker SSI Laser Engineering (Nashville, Tennessee) suggested an unfamiliarity with quality systems requirements – or at least the current interpretation of those requirements – that defies credulity. The warning letter, which barely ran over to three pages, was short and to the point, citing SSI for, among other things, failure to "establish procedures to define the management review system" and for failure of procedures to require "the signature of the approving [company] official."
Between these first and last citations, FDA states that employees were not trained on the quality systems regulations and that service technicians working for distributors had not been trained on service requirements and procedures.
FDA said the firm's CAPA procedure "does not address evaluating data from returned merchandise authorizations, service reports and other sources" of quality data. At press time, SSI had not responded to a call for comment.