Covestro polycarbonate makes oxygenators safe and durable
Makrolon® polycarbonate from Covestro ensures maximum safety for patients when used in this membrane oxygenator from Wego New Life Medical Devices. The medical-grade plastic is transparent and exhibits high impact strength. Besides this, the material is biocompatible. (Picture source: Wego New Life Medical Devices)
Leverkusen, February 28, 2017. Membrane oxygenators, popularly known as artificial lungs, can be used to replace lung function during open heart surgery by oxygenating blood outside the human body. This requires its material to have good blood compatibility and durability. Wego New Life Medical Devices Co., Ltd, a well-known medical device manufacturer in China, has found Covestro polycarbonate an ideal material for membrane oxygenators to ensure safety for patients.
“Thanks to its outstanding balance of properties, medical-grade Makrolon polycarbonate from Covestro makes oxygenators safe and durable,” says Chengwu Liu, Production Director of Wego. The glass-like clarity of Makrolon® 2458 polycarbonate makes for an entirely transparent shell that enables clear observation of the proper functioning of the oxygenating process. The polycarbonate also exhibits high impact strength and reduces the risk of accidental damage during the course of a surgery. Its biocompatibility has been tested according to ISO10993-1, ensuring highest safety for the human body.
Various applications in medical technology
“Covestro polycarbonate is widely used in medical applications, and we have partnered with Wego in many medical devices including dialyzers and oxygenators,” says Mo Liu, Director of China Market Development of Covestro Business Unit Polycarbonates. “We want to bring Makrolon polycarbonate to more medical applications in China based on the proven successful cases in Europe and North America.”
In the “Twelfth Five-Year Plan”, the Chinese government has made a commitment to improve medical insurance to prevent poverty caused by illness. Today, patients are able to enjoy appropriate medical services at reasonable prices thanks to the medical insurance plans. This has presented enormous opportunities for local manufacturers in the medical device industry.
“Wego is committed to setting an industry benchmark,” says Chengwu Liu. “We’ve established a close partnership with Covestro in the design and production of oxygenators since 2008 and reached a proper balance between benefits and costs.”
Polycarbonates for various requirements
Covestro has been committed to enabling innovation in the medical equipment industry through the development of high-performance materials. Medical-grade Makrolon® polycarbonate has been used in medical devices as early as the 1970s.
High heat medical polycarbonate APEC® 1745, a unique product from Covestro, provides proven performance and features a unique combination of properties, including high heat resistance, impact strength and glass-like transparency. These properties are ideal for supporting and enhancing the sterilization process of small, non-invasive medical devices, a growing trend for medical technological advancements. APEC® 1745 is suitable for repeated steam sterilization up to 143 degrees Celsius. This resin has easy-release characteristics, high softening temperature and good hydrolysis resistance and is biocompatible according to ISO 10993-1 test requirements.
Makrolon® Rx medical polycarbonate series has good heat resistance and is able to tolerate high energy e-beam and gamma radiation sterilization. This is extremely important to dialyzers, intravenous injection equipment and other medical and surgical devices. After undergoing gamma ray radiation sterilization, it is still able to maintain color stability and mechanical properties. Large scale sterilization also becomes possible.
Testing through biocompatibility
Covestro implements strict product quality management. Medical grade polycarbonate materials must undergo testing for biocompatibility and meet the requirements of ISO 10993-1.
Makrolon® polycarbonate from Covestro has been used for many years in medical devices approved by the U.S. Food and Drug Administration (FDA). Biocompatible medical grade polycarbonate has good regulatory assessment evidence to support device registration and traceability, which can help device manufactuers shorten the time needed to bring their products into the market.