Tainted Heparin: It's Still Out There, and Still a Concern

Angier, NCVarious pieces of news on the tainted heparin front of late further fuels the concern for the nation's heparin supply, and the safety of patients who rely on the drug.

Last month Medtronic recalled a collection of heparin-coated products commonly used during cardiopulmonary heart surgeries, given that the disposable products were manufactured with tainted heparin from China. The contaminant, oversulafted chondroitin sulfate (OSCS), is the same substance found in the recalled lots of injectable heparin.

While there have not been any reports of adverse reactions linked to these products, it is unclear if exposure to medical devices coated with relatively small amounts of contaminated heparin would have the same impact to an individual's health as exposure to injectable heparin tainted with the same contaminant.

The recall was carried out as a precaution, and affects various disposable devices such as blood oxygenators, reservoirs, pumps, cannulae and tubing packs that all feature a Carmeda BioActive coating.

Medtronic has also advised its customers in the medical community that some lots of Trillium-coated products were also manufactured with OSCS-tainted heparin, but at levels significantly lower than that affecting the Carmeda products. This is the reason that Medtronic chose to advise the market of the problem, but stopped short of issuing a recall. The company stated that while its ultimate goal is to remove the contaminated Trillium products from the market, it maintains that based on current data the benefits extending from use of the product outweigh the potential risks.

Meanwhile, the American Medical Association (AMA) has tagged up with the US Food and Drug Administration (FDA) to warn that injectable heparin contaminated with OSCS may still be in circulation, and are asking physicians and other health care professionals to do an inventory of all drug and device storage areas, in an effort to ensure that all recalled heparin products are properly removed. The storage areas at issue include emergency kits, dialysis units and automated storage cabinets.

And, in a case unrelated to the OSCS-contaminated heparin from China, pre-filled heparin syringes manufactured by AM2PAT Inc. have been linked to five deaths and 100 cases of Serratia blood infections, affecting both adults and children, nationwide.

It has been reported that during November and December of last year, patients in Texas and Illinois were hospitalized after using Sierra Pre-filled heparin syringes made by AM2PAT Inc.

According to court documents that are part of an internal investigation, AM2PAT was "manufacturing injectable fluids under non-aseptic conditions and manufacturing operations were not in compliance with acceptable, good manufacturing practices."

What's more, court records show that the manufacturer, based in Angier, North Carolina was routinely shipping medical devices before safety testing, or the testing of lots had been administered.

Ravindra Kumar Sharma, the former director of quality control for the company, is facing a host of federal charges stemming from the alleged falsification of documents and required testing. During an inspection of the AM2PAT facility in December, the FDA found that the company was "not in compliance with quality system regulations and had failed to have adequate controls to ensure necessary sterility of its pre-filled syringes."

As a result of the inspection, the FDA was compelled to issue an urgent communiqué in the same month warning against "bacteria infection (that) could present a serious adverse health consequence that could lead to life-threatening injuries and/or/death."