Examining 68 hospitals in seven of China’s major regions, the researchers’ study identified over 2,100 case patients affected by HAIs and found, on average, that these infections caused an increase in hospital length of stay by 10.4 days. With the prevalence of these types of cases in mind, new legislation and regulations continue to emerge in China, pushing for better patient outcomes and greater healthcare worker safety. As such, it is imperative that high-quality innovations for decontamination and sterilization are available for manufacturers—and, ultimately, end users—in the medical device industry. Lifesaving and health betterment procedures often leave patients vulnerable to HAIs, especially when the instruments used in these procedures are not properly sanitized.
HAIs, while ranging in severity, can lead to debilitating illnesses—and, in some cases, death. The use of catheters, injections, or the improper use of antibiotics are all factors that increase the risk of HAIs. While they can occur in any healthcare facility including hospitals, ambulatory surgical centers, end-stage renal disease facilities, and even long-term facilities, the infections are usually the result of bacteria, fungi, viruses, or other, less-common pathogens entering the bloodstream. Some common HAIs that patients contract are central-line associated bloodstream infections, Clostridium difficile infections, Methicillin-resistant Staphylococcus aureus infections, and urinary tract infections, among others. In some cases, surgical instruments that are poorly sanitized, maintained, or stored can lead to a surgical-site infection. About one in 31 hospital patients acquires an HAI on any given day as a result of poor cleaning or disinfecting practices around a surgical procedure alone.2
To address this concern, medical device manufacturer Guangdong Xianfeng Medical Technology Co. Ltd. approached Porex, a global provider of porous polymer solutions, for help in improving the sterilization process for surgical equipment used in healthcare environments. Specifically, Xianfeng was looking to incorporate a more robust, reusable filter that would enable necessary venting within its medical container and also serve as a strong barrier to bacteria attempting to contaminate the sterile environment.
Xianfeng is constantly seeking to enhance its products in order to meet the changing needs and demands of the Chinese market. The manufacture of sterile containers, which are used in many diverse medical environments to sterilize surgical instruments and maintain sterility until use in surgery, is a growing market for China.
Typically, medical containers are equipped with single-use paper and textile filters during the steam sterilization process, which help to vent the device. If performing as they should, these filters should allow proper venting that creates the correct levels of pressure in the sterile container and also block the entrance of new bacteria. The issue with these materials is they can only be used once, requiring replacement after a single use. If the filters aren’t changed regularly, healthcare workers risk tainting the instruments undergoing sterilization. Thus, the Chinese manufacturer turned to Porex for help in developing a new type of filter, aiming to solve a technical design challenge and enhance the sterilization process.
Porex worked with Xianfeng for more than half a year to select a customized porous polymer solution for the medical container. Ultimately, the filter would serve a dual purpose: to function as a vent to allow pressure equalization during the sterilization process and as a barrier to bacteria during subsequent storage.
Porex provided Xianfeng samples of its proprietary Virtek sintered PTFE material to test in its sterile containers due to its ability to withstand thousands of repeated sterilization cycles. The success of the project depended upon optimizing the correct pore structure and surface characteristics, ensuring the final product was more durable and reliable than paper or textiles and could be permanently imprinted with a batch identification and date code to monitor usage.
Sintered PTFE is a material with high temperature and chemical resistance. Virtek’s manufacturing process results in a material with an intricate network of open-celled, omni-directional pores, which together deliver a different level of performance. The end product is a durable, design-flexible 3D material that doesn’t require a supporting layer or scrim. The unique composition of Virtek provides reliability during the manufacturing process and beyond, offering long-term value for the manufacturer and end user.
When used as a sterilization container filter, the Virtek venting solution challenges the industry standard material and allows for greater infection control. The PTFE filter offers superior hydrophobicity and chemical resistance, as well as high-temperature stability. It also provides high bacterial filtration efficiency of 99.99 percent or higher, superior water-entry pressure, optimal airflow, and a fluid barrier. The Virtek filter helps to promote active infection prevention, making it a suitable choice for Xianfeng’s medical storage containers.
Xianfeng also recognized the Virtek technology introduced a new concept to the market that became known as a permanent “fit-and-forget” filter due to its ability to withstand up to thousands of autoclave sterilization cycles. Its high reusability rate also minimizes downtime and improves production efficiencies by reducing the frequency with which healthcare workers have to replace the filter. In addition, the flexibility of Porex’s manufacturing process offered Xianfeng a cost-efficient alternative to traditional materials along with substantial performance advantages.
Equipped with Virtek PTFE as a filter, the Xianfeng containers are able to be employed to properly sterilize surgical instruments and maintain sterility until use in surgery, ultimately reducing the risk of infections in hospitals, dental offices, outpatient centers, and other medical practices. With the sintered PTFE technology improving the sanitization process, Xianfeng believes the market for medical sterilization containers will grow in China in the near future, allowing the industry to move away from single-use disposable filters and take steps toward supporting greater patient care.
Jack Chan is the global marketing director for Porex’s medical market (www.porex.com) with more than 20 years serving the medical device industry. He is responsible for driving Porex’s medical marketing strategy through his extensive experience in working with medical grade polymers used in medical devices. Chan received his Ph.D. in physical chemistry of polymers from the University of Texas—Austin, a Master’s of Science in polymer science and engineering from the University of Massachusetts in Amherst, and double Bachelor of Science degrees in polymer science and chemistry from the University of Southern Mississippi.