Medical Device Daily Washington Editor

WASHINGTON — The Quality Systems Regulations (QSRs) that FDA uses to help device makers stay in good form have been around for some time, but two of the major elements of that part of the federal code still bedevil device makers large and small.

In warning letters the agency posted on its web site last week, one of the world's foremost imaging manufacturers snared one such letter for lapses in design validation and corrective and preventive action, resulting in a recall of magnetic resonance coils; and a smaller firm making ventilators ran afoul for not fixing a problem with backup batteries, a problem that surfaced in consecutive inspections.

The agency's warning letter to GE Healthcare Technologies (Waukesha, Wisconsin) listed six citations for operations at the company's subsidiary USA Instruments (USAI; Aurora, Ohio) that manufactures magnetic resonance (MR) coils for imaging equipment. The inspection, which ran from Nov. 6 to Dec. 19, disclosed that USAI had shipped breast biopsy plates to customers prior to completing package integrity testing and prior to approval of the sterilization procedure used by an entity, presumably a third party, whose name was redacted.

Cincinnati District director Carol Heppe, author of the letter, wrote that that the company's response to the observations was "inadequate." that she found "your response to this portion of the observations … adequate."

Under this same citation, the company was cited for failure to validate the design for a 1.5 Tesla MRI coil for head, neck and spine imaging prior to the date of sale last May.

For this citation, FDA found the company's response was "incomplete" because the firm did not "indicate how you will prevent devices with incomplete design validation from being released in the future."

The second citation in the warning letter involved breast biopsy plates that GE had to recall because a "previous contract sterilizer" had not conducted "revalidation activities since 2000" and because USAI had no documentation "of the acceptance of the sterilization protocol or results." FDA found the company's response to the 483, the abbreviated form outlining deviations from regulations, adequate, but the warning letter offered no further detail on the recall.

USAI took in a citation for another of the four major areas of the QSRs, namely corrective and preventive action (CAPA).

In reference to a problem that surfaced in March 2004, the company "identified soldering issues as one of the top three manufacturing defects," but despite off-site training to boost the employees' soldering skills, training records for nine of 17 employees were incomplete, missing, or indicated that the employee failed a soldering test.

According to FDA, another CAPA file from last year indicated "that solder defects are still a major issue at your firm," and the letter stated that the company's response did not address "how you will assure that your corrective actions actually correct the problems."

USAI was said to have failed to have processed complaints "in a uniform and timely manner" in that the company had more than a dozen safety complaints and quality reports that were past due. Several with coil reliability issues and another was due to the failure of a coil capacitor. The warning letter stated that the firm had committed to "devoting more resources to this area of your operation" and asked for an update.

At press time, the company had not returned calls for comment.

The Feb. 21 warning letter to Newport Medical Instruments (Costa Mesa, California), a manufacturer of ventilators, offered substantial detail for eight deviations from the QSRs, and closed by urging the company to include in its response "the actions you have taken to correct the continuing complaints involving the HT-50 battery life and shut-downs without proper warning."

The passage was in reference to a CAPA citation for failure to document and track failure investigations for the firm's HT-50 Homecare ventilators. The warning letter indicated that FDA found the response to this finding adequate, but the agency expressed "concerns regarding your firm's corrective actions" for the HT-50 shutdowns.

According to the warning letter, a January 2005 inspection of the company's plant found that it was "receiving complaints" the previous year, but the November 2006 inspection, which led to the warning letter, "revealed that you are still receiving similar complaints."

The Newport warning letter also cited the company for failure to document reviews and approvals for design changes for a ventilator, the model number of which was redacted (the firm's web site lists five ventilator models).

FDA's Los Angeles District director, Alonza Cruse, wrote in the letter that the updated procedure "does not address documenting the design reviews with meeting minutes … and you have not provided a mechanism for address incomplete, ambiguous or conflicting requirements." The inspection of Newport ran from Oct. 31 to Nov. 7.

Rymed Technologies (Franklin, Tennessee), makers of the Invision-Plus intravenous infusion kits, came under the agency's scope in an Oct. 18-Nov. 8 inspection of its plant in Austin, Texas, which may have been prompted by a recall earlier last year of an unspecified number of units of its Neutral line of connectors for the Invision kit.

According to the warning letter, Rymed did not "ensure that all the affected lots of the referenced devices were effectively retrieved from the market" and did not adequately ensure that all users were adequately notified of the recall in order to prevent further use.

The connector weld was the subject of the first finding, which alleged that the company "neither monitored the validated welding process via an increased sampling plan nor reviewed the test results of the weld integrity of the female luer and the spike body in order to detect changes in the welding process" that led to failures which, in turn, prompted a recall of ten lots of the connectors.

The warning letter said that a third party handled the welding process for Rymed.

The letter cited Rymed further for failure to notify FDA of the withdrawal of the devices from the market within 10 days, as required by law, and for failure to update the agency on changes to the addresses of its manufacturing facility and its administrative offices.