Medical Device Daily Washington Editor

Findings of problems with a manufacturer's systems for corrective and preventive actions (CAPAs) and complaint handling are not uncommon in FDA inspections, but a recent inspection of Ohio Medical (Gurnee, Illinois) indicated that the manufacturer of intermittent suction units encountered substantial problems with those systems in connection with electronic control components. Unfortunately for the company, the agency also had problems with the firm's responses to the inspectional findings, leading to a July 22 warning letter with five citations.

According to FDA, corrective action problems included a failure to initiate a CAPA for seven complaints received between October 2008 and February 2009 in connection with intermittent suction units "that were verified to be caused by intermittent timing not meeting specifications." FDA added, "two of these complaints . . . were found to be out-of-box failures for the timing drift problem."

The warning letter added that a review of device history records showed that 50 non-conformances from three lots of the suction units were out of specification for a timing module, and that the percent standard deviation calculation for "on and off times" was "below the target" for another three lots. The agency alleged that Ohio Med did not open a CAPA for these latter incidents as well.

Another incident that the company is alleged to have not investigated involved three complaints received between January and March 2009 for "cracking of plastic vacuum collection bottles." FDA said that the supplier of the bottles "was found to have changed" the material from which the bottle was made, but that the inspection of incoming bottles failed to note the change. The agency says in the warning letter that a reference source, which FDA did not cite, advises not to autoclave the bottles for sterilization because of the potential for weakening the plastic. The agency alleged that Ohio Medical did not initiate a CAPA for this incident until after the inspection was underway.

FDA deemed the firm's June 16 response to the inspectional findings inadequate because of lack of supporting documentation for the first two sets of incidents, and the agency added, "the response does not address any corrective action to the incoming specification for the vacuum collection bottles to verify coloring or composition upon receipt."

Control of non-conforming product was also an issue in the second citation, but served as the headliner. The warning letter states that Ohio Med used two valve plates described as "damaged" in the assembly of suction units, but could not document the rationale for having done so. The company is said to have been unable to locate the on-conformance reports for two other valve plates, one of which was said to have been damaged, but which "the engineer said to use anyway."

Also in this citation, FDA wrote that the company had to replace timing module assemblies in nine intermittent suction pumps "because the units failed during production testing." The problem FDA had with this finding is that company records note this problem in the non-conformance log as part of "716 non-conforming timing module assemblies over an unspecified period of time" in an April 2009 entry into the log despite that the nine units in question were manufactured and/or integrated into suction pump units between Jan. 28 and Feb. 4, 2009.

Despite FDA's unhappiness with what it alleged was a failure to document an investigation into the timing module non-conformance, the agency found the firm's response adequate, noting that the matter will be revisited in the next inspection.

In an e-mailed statement, Ohio Medical's CEO, David Finney, told Medical Device Daily that the firm "take[s] our quality systems very seriously" and that the "new procedures and corrective actions are on track to be completed within the schedule already provided to the FDA." Finney also said Ohio Med is "confident that these corrective actions will further enhance our quality systems."

TENS maker cited for design change

The July 1 warning letter to Electro-Tech Products (Glendora, California), maker of transcutaneous electrical nerve stimulators (TENS) led with a citation for failure to obtain a PMA or an investigational device exemption for the company's Mens-O-Matic IV TENS units. FDA stated in the warning letter that the unit was cleared in 1991 "for symptomatic relief of chronic intractable pain." However, because the firm changed the frequency of the device's electrical pulse and its waveslope and modulation rise time, the agency has decreed the device under its new design as a new device, at least until the company cites a predicate. According to FDA, the design change also incorporates an interferential frequency, a change FDA said could have an impact "on high frequency surgical equipment."

FDA did not put much effort into detailing the quality systems findings from the January-February inspection, listing for instance that the firm acknowledged "it has not established a design history file for the Mens-O-Matic IV-A." FDA indicated that the firm's Feb. 26 response fell short of satisfactory because "you did not address your failure to establish a design history file for the Mens-O-Matic IV-A TENS device."

Similarly brief was the finding that Electro-Tech acknowledged, "that it has not performed installation, operation, and performance qualification studies for" a piece of equipment the identity of which was redacted.

However, the agency added that "the wave soldering system is not a process that can be fully verified by [visual] inspection because the circuit board electrical integrity can be compromised during the manufacturing process; accordingly, the soldering process requires validation."

Electro-Tech apparently pleaded ignorance to at least one essential element of the quality systems regulations. FDA cited Electro-Tech for failure to "develop, maintain, and implement written medical device reporting (MDR) procedures for internal systems," and said that the firm's response to this finding is "inadequate because it states that you were unaware of the MDR requirements, and you have not provided any written MDR procedures."

The company did not respond to a call for comment.