Originally Published MDDI July 2005
|Guayule in its natural state. The plant is being looked at for applications in which it could be used as an
alternative to latex for medical device applications.
After years of controversy over devices containing natural rubber, a natural alternative may finally make it to market.
In 1998, after noticing an increase in the number of deaths associated with patient sensitivity to natural latex proteins, FDA decided to take action. It encouraged manufacturers to find alternatives to natural rubber. It also issued a rule requiring prominent labeling on devices that contain either natural rubber latex or dry natural rubber.
Manufacturers typically switched to synthetic substances, but for some products that wasn't possible. Now it might be, thanks to a newly discovered natural latex substance that does not 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 natural latex source, guayule could become a significant product in the medical device market. “Right now there are a number of devices for which synthetic polymers haven't proven 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.”
|Katrina Cornish of Yulex Corp. examines vials of purified guayule latex. The only domestic natural latex source, guayule could become significant in the latex market.|
A recent study from The Johns Hopkins University (Baltimore) also cited guayule natural rubber latex 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 natural rubber latex that's been found safer for use in medical devices,” says Martin. “As we gear up and capacity increases, medical device manufacturers and hospitals will have a choice.” The new substance has potential for use in hundreds of devices, such as gloves, catheters, anesthesia equipment, and adhesives.
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 for now.
“There hasn't been any significant innovation with respect to natural rubber latex, or for that matter, significant innovations with synthetic latex,” says Martin. “This technology has the ability to transform that portion of the industry.”
Copyright ©2005 Medical Device & Diagnostic Industry