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Manufacturer Says Problems Corrected

June 27, 1985

WASHINGTON (AP) _ A California company that produces artificial heart valves under attack by a consumer health organization says it has corrected problems identified last year in a Food and Drug Administration inspection.

Larry Wettlaufer, director of sales and marketing for Shiley Inc., said Wednesday the company has notified FDA of the changes and ″believes that it has been fully responsive and that its responses were found to be satisfactory by the agency.″

The Health Research Group, an organization founded by Ralph Nader, asked the FDA on Wednesday to recall unimplanted stocks of the Bjork-Shiley 60- degree Convexo-Concave Heart Valve, manufactured by Shiley, based on FDA inspections last year that cited the company for serious deficiences in manufacturing.

Violations cited by the FDA, and detailed in an April 11 letter to the company, include failure to adequately train workers; failure to test finished heart valves; failure to record the number of times a valve is subjected to welding; and failure to adequately investigate valves that broke.

In a letter to FDA Commissioner Frank E. Young, the Health Research Group said the problems should cause FDA to recall unimplanted valves, arguing that the warning follows at least 140 cases of valve failure, including 93 resulting in death, because of it had made or was implementing several changes in its operating procedures, documentation and inspection standards as a result of the FDA’s observations,″ Wettlaufer said.

″The April 11, 1985, letter requested re-confirmation from Shiley that these changes were implemented and Shiley Inc., believes that it has been fully responsive and that its responses were found to be satisfactory by the agency,″ he said.

The FDA’s April 11 letter said further action would be taken if Shiley did not adequately correct the problems. Wettlaufer said FDA has taken no such action.

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