Unsterile IVs

Unsterile IVs

Certain medical devices--such as tubes and needles for administering medicine through a vein--must be sterile. If they're not, they can make a sick patient even sicker. So, when FDA received a report about possibly contaminated intravenous (IV) sets, it immediately looked into the problem. The investigators followed a tangled trail that led to Stamford, Conn.; Jamaica, Hauppauge and Brooklyn, N.Y.; and even Como, Italy (via the telephone). The case was finally resolved last January with the destruction of more than 48,000 IV sets imported by a New York City firm, D.R.O. Medical Products, Inc.

The case actually goes back to 1983. That's when Centaur Sciences, Inc., of Stamford, began receiving the D.R.O. sets, which were made in Como, Italy, by a sister firm, D.R.O., Medical Italiana, S.P.A.

During a routine inspection of Centaur in April 1985, an FDA investigator from the Boston office learned that Centaur was recalling several lots because it had found some sets in those lots to be defective and some labels incorrect. The investigator took samples for testing. Indeed, although no injuries had been reported, FDA's laboratory analysis showed that many sets had defects that could permit contamination by bacteria and other potentially dangerous substances.

But FDA found fault with Centaur's recall and reconditioning strategy. Merely telephoning its customers to return the sets and checking sterility on only some of the returned sets was inadequate, said FDA. The agency advised the firm that proper recall procedures include such steps as sending letters with mailback response cards and testing all sets for sterility. Centaur complied with FDA's advice, and FDA monitored the recall to completion.

Centaur refused a further D.R.O. shipment (though a subsequent legal judgment required Centaur to pay for it) and relayed to FDA's Boston office concern that this lot might be sold to another dealer who, unlike Centaur, might accept and distribute the possibly defective sets. Centaur thought the new shipment might be at Shankers International Forwarders, in Jamaica, N.Y. FDA's Boston office passed this on to the Brooklyn office, which sent an investigator to Shankers on Oct. 25, 1985. It turned out that the firm had no warehouse and was only a broker for D.R.O.

Next, the investigator went to D.R.O. and informed the firm that FDA had found defective sets in the lots at Centaur, that those lots were being recalled, and that this new shipment might be defective, too. The investigator also called the manufacturer in Italy. The quality control manager there said Centaur had added filters to the sets and then re-sterilized them, but that he never saw the modified sets. When asked about the incorrect labels, he said he had received all labeling and instructions from Centaur. D.R.O.'s invoices indicated that Centaur's undelivered order was stored at Savoy Medical Supply Co., Inc., in Hauppauge, N.Y.

On Nov. 4, 1985, however, D.R.O. notified the investigator that the IV sets weren't at Savoy, after all, but at World Wide Consolidators, Inc., at the Brooklyn Navy Yard. That same day, FDA began a four-day inspection of World Wide. Samples were taken, and more than 20 percent were unsterile because of such package defects as perforations, unclosed seams, fibers resembling hair and eyelashes, and particles of foreign materials. Testing of intact units, however, showed them to be sterile.

The inspection at World Wide turned up defects beyond the IV sets; defects, in fact, with the warehouse itself. For example, labeling for the devices called for protection from moisture, freezing and excessive heat, yet the sets were stored where there was no temperature control.

FDA investigators also visited Savoy Medical Supply. The firm was a customer of D.R.O. and had stored the sets as a favor. Examination of other stored D.R.O. products and the storage area revealed no problems.

When FDA again visited D.R.O., on Jan. 8, 1986, the defective IV sets were still offered for sale. FDA pointed out the results of FDA's tests on the sets to get the firm to recondition them. D.R.O. refused, contending that the sterility of the tubes' fluid pathway was ensured by caps over both ends of the sets. One end has a needle; the other has a spike that attaches to the drug container. But the caps didn't seal the sets. They were only pressure-fitted, and FDA doesn't consider that an adequate bacterial barrier.

On Feb. 12, 1986, FDA's Brooklyn district office recommended that the devices be seized by the courts. A request for a decree of seizure and condemnation of the IV sets was filed Nov. 18, 1986, in the U.S. District Court for the Eastern District of New York. The decree was granted, and a U.S. marshal destroyed the sets in an incinerator on Jan. 22, 1987.

COPYRIGHT 1987 U.S. Government Printing Office
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