Magazine article FDA Consumer

Surgical Stockinettes Destroyed

Magazine article FDA Consumer

Surgical Stockinettes Destroyed

Article excerpt

Adulterated surgical stockinettes with an estimated value of $58,000 were destroyed last April 23 after a deputy U.S. marshal seized them at FDA's request. Though labeled "sterile," they were manufactured under conditions that couldn't ensure sterility.

Surgical stockinettes, regulated as medical devices, are used during artery transplantation and bone surgery. They must be sterile and resistant to shedding or attracting lint so that they don't contaminate the open wound.

Etex Co., a subsidiary of Eagle Beef Cloth Co., Inc., at Hauppauge, N.Y., had offered the "sterile" stockinettes to fulfill a contract with the U.S. Department of Defense. When a government contract involves an FDA-regulated product, FDA's Government Wide Quality Assurance Program calls for inspection of the manufacturer to determine whether the product conforms with requirements of the contract and FDA's good manufacturing practices. Under previous defense contracts, Etex had provided other acceptable devices--such as elastic rubber bandages, which aren't required to be sterile--but this was the first "sterile" product to be manufactured at Etex.

In March 1990, FDA's New York district office sent investigator Peter Abel to visit Etex. Abel found the firm did not monitor and control the environment to prevent contamination of the stockinettes. Indeed, he saw lint contamination throughout the plant, even built up so thickly on light fixtures it was actually hanging over.

The inspection revealed, among other deficiencies, that the firm did not properly over-wrap the stockinettes for protection, test for product degradation during the radiation sterilization process, test the packaging to ensure integrity from manufacture and sterilization through distribution, keep proper records, or properly train its employees. Abel informed Etex of the deficiencies and of his conclusion that they made the product unacceptable. …

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