Articles
Pall Breathing Filters Validated as a Prion Transmission Barrier; Eases Growing Concern About Transmission of variant CJD During Anesthesia Procedures
January 14, 2004
Medical procedures in which patients share life-saving devices pose an especially high potential risk of cross infection. This may be problematic with prions due to their long incubation period where there are no signs or symptoms of disease and no tests to determine their presence in humans. It is current practice in certain anesthesia locales to reuse the breathing circuit between patients, when a filter is used at the patient end. The Pall Ultipor 25 Breathing System Filter is designed to protect breathing circuits and ventilators against patient cross contamination and has been validated against a host of pathogens.
"The presence of blood secretions in a high percentage of intubated anesthesia patients' airways presents a potential cross infection risk from prions as well as other agents," said Karen Wilkins, Director Scientific and Laboratory Services, Pall Medical. "This laboratory study specifically validates our breathing system filters against prions from entering the breathing circuit." The study was performed to test Pall Breathing System Filters for their specific ability to retain the abnormal form of prion proteins that have been found to be the causative agent of Transmissible Spongiform Encephalopathies (TSEs) in a simulation of their clinical use in anesthesia ventilation.
"These results are especially fortuitous with the new understanding that prions may be transmitted through blood," said Eric Krasnoff, Pall Chairman and CEO. "This research is just one step in Pall's ongoing commitment to provide the safest medical treatments possible and on our ongoing prion research program. Our prion research is also developing a filter to remove these rogue proteins from donor blood," he added.
Pall is currently involved in aggressive research programs using its proprietary technologies to remove prions from blood and to detect prions. The Company recently announced preliminary results of a study that found that a prototype leukocyte (white blood cell) reduction filter, containing new proprietary media, was effective in reducing infectious prions below the level of detection, specifically from scrapie-infected red blood cell concentrates. It plans on presenting results of this study at the International Society of Blood Transfusion later this year. Pall is also working on a system to detect prions in blood for early identification of infected animals before they manifest clinical signs or symptoms of disease and prior to their use as a food source.
Prions are the latest infective agent for which the Pall Ultipor 25 filter is validated to reduce. These breathing system filters are also validated against a host of bacterial and viral pathogens with a microbial rating of 99.999 percent using a monodispersed aerosol challenge, the most stringent in the industry. Its hydrophobic (repels liquids) media provides an absolute barrier to a liquid challenge, specifically secretions which include blood.
The Ultipor filter was recently recommended to help stop the spread of Severe Acute Respiratory Syndrome (SARS) in hospitals in both anesthesia and respiratory care. In June 2003, both the Taiwan Respiratory Society and the Ministry of Health and Long-Term Care in Ontario, Canada (two areas of the world hardest hit by SARS) recommended the use of high-efficiency breathing filters to help prevent disease transmission. They issued directives to use only filters that are hydrophobic and demonstrate high levels of viral retention to prevent contamination of equipment and cross contamination between patients.
Pall markets the Ultipor 25 filter worldwide for use in anesthesia. About 15 million surgical procedures are performed annually in Europe, and 45 million worldwide, where general anesthesia involving endotracheal intubation is employed. These procedures can range from minor surgeries, such as a tonsillectomy or removal of an ingrown toenail, to major operations such as orthopedic and cardiovascular surgery.



