Maria Fontanazza 
After years of controversy over parenteral and medical device packages that contain natural rubber, a safe natural alternative may finally make it to market.
In 1998, after noticing an increase in the number of deaths associated with patient sensitivity to certain natural latex proteins, FDA decided to take action. It encouraged manufacturers of medical devices and of healthcare packaging to find alternatives to natural rubber. It also issued a rule requiring prominent labeling on devices or packages that contain either natural rubber latex (NRL) or dry natural rubber.
Manufacturers typically switched to synthetic substances, but for some products, that wasn’t possible. Now there may be another solution, thanks to a natural latex substance that was discovered not to contain the harmful proteins.
“Everyone looking for a solution to the problem has looked to synthetics,” says Jeffrey Martin, president and CEO of Yulex Corp. (Carlsbad, CA). Yulex manufactures latex extracted from the desert plant Guayule (pronounced why-you-lee). The company has an exclusive license on the technology, which the U.S. Department of Agriculture first developed.
Free of tropical proteins and the only domestic NRL source, Guayule latex could become a significant product in the latex devices market. “Right now there are a number of devices for which synthetic polymers haven’t proved acceptable,” says Martin. “There are several different areas of catheter products where synthetics aren’t used, even though there’s such a high liability using tropical latex.”
A recent Johns Hopkins University (Baltimore) study also cited Guayule NRL as a possible safe alternative to its tropical counterpart, hevea brasiliensis. Yulex provided Guayule materials to support that research.
“We now have a domestic source of NRL that’s been found safer for use in medical devices,” says Martin. “As we gear up and capacity increases, manufacturers and hospitals will have a choice.”
Hundreds of devices and types of packaging have potential in this market.
Yulex plans to make its first sales this year. “It’s going to be priced competitively with the synthetic materials,” says Martin, predicting that the first applications will be in catheters and surgical gloves. He said the company has agreements with several device companies, but their identities are confidential.
“There hasn’t been any significant innovation with respect to NRL, or for that matter, significant innovations with synthetic latex,” says Martin. “This technology has the ability to transform that portion of the industry.”