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The World Biomaterials Congress is coming soon. You may want to make your travel plans now *if you haven’t already. Sponsored by the European Society for Biomaterials, the Netherlands Society for Biomaterials and Tissue Engineering and International Conference Services BV, the 8th annual conference will be held May 28 through June 1 at the RAI International Convention Centre in Amsterdam, The Netherlands. Arrange travel, book your hotel, and download conference session at www.wbc2008.com.

When Baxter Corp. suspended production of multidose vials of the blood-thinner heparin following reports of hundreds of patients experiencing severe allergic reactions, it raised fears of a shortage. For this reason the company held off recalling all batches in the field. The company initially recalled nine batches and then extended the recall to remaining lots when competitors were able to meet demands in February.

Heparin is used in dialysis and heart procedures to avoid blood clots in veins, arteries, and lungs. It is also a commonly used coating for medical implants, such as stents.

The source of the contamination seems to be from Scientific Protein, a company that closed its China-based factory amid an investigation into the life-threatening allergic reactions. FDA has said a foreign “heparin-like” substance was found in up to 20% of the suspected batches of heparin sold by Baxter. FDA said heparin’s active ingredient might have been tampered with during production in China at Scientific Protein’s factory or in the supply chain leading up to the factory. However, at this point it is unclear whether the contamination can be linked only to that manufacturer, or is a larger problem.

In early March the threat expanded to Germany, which also recalled heparin products. The country does not carry Baxter’s product, but it does initially source its products from China. On March 11, three Japanese companies recalled the product as a precautionary step.

The risk for the device industry may not be significant, says Joel Gorski of NAMSA. The reaction, he explains, only comes from fairly large doses, which wouldn’t be used for devices. “In devices, heparin is covalently bound, and so would not be released in the body. In addition, there are other coatings that could perform desired functions for a device,” he says.

However, Gorski also said that what FDA finds during its investigation could affect implant surgeries and heparin sources for devices. “It depends on how widespread the problem is,” he says. If the problem is from a single source in China, then the device industry will be largely safe. If, however, the problem is on a larger scale, it could affect industry. “Just the process for implanting devices often requires that patients be heparinized. This could have a significant effect.”