TWSpecial Report
Donald J. Wagner II博士发明了该专利硅的抗微生物聚合物，称为BioSafe，目前是Gelest Inc.的技术营销经理。在获得独家许可协议之后，2016年，GELEST在4月从BioSafe Inc.获得了BioSafe Technology。2017年，HM4100抗菌剂（以生物安全为销售）获得了美国环境保护局（EPA）的食品接触底物注册，并于2017年7月获得该产品根据NSF 51获得了食品接触的认证。瓦格纳（Wagner）于2001年毕业于弗吉尼亚理工大学和州立大学。
188BET金博宝下载: What is currently happening in the antimicrobial market for medical textiles, and what are companies focused on?
Wagner: Fashion, function and controlling costs are probably the three biggest things. Scrubs have become fashionable and even a pseudo-status symbol for health care professionals such as nurses and doctors.
医疗纺织品功能很重要，因为纺织品是医护人员及其患者之间的障碍。磨砂膏不仅是工作人员的统一，使患者和家庭成员很容易识别医护人员，而且也是身体上的障碍。
医疗纺织品的流体屏障可能是疏水性和含水性的。流体屏障技术的最新进展有助于磨砂膏和其他可能含有引起疾病微生物的流体。纺织品排斥液体的能力对于保持纺织品清洁很重要，但是有一些新技术可以在连续且持续的基础上为纺织品本身提供抗菌性能。这些技术控制纺织品中的微生物，使它们无法成为与医疗保健环境相关的微生物传播的矢量。
TW: What characteristics or properties does the medical community require for medical textiles?
Wagner: The key is protection. The fluid barrier and antimicrobial chemistry add a unique level of protection that a standard textile lacks. The Journal of Hospital Infection in March 2015 pointed out that healthcare textiles, including uniforms and apparel, are vectors for transmission of microorganisms that cause infections and illness to healthcare workers, patients, and the community. The impact is underestimated because of the lack of point-source investigation of textiles during outbreaks.
TW：制造商在市场上推出新的抗菌纺织品时必须考虑哪些因素？
Wagner: Price and performance. The medical textile that has excellent fluid barrier properties and antimicrobial performance is certainly valuable, but it may not warrant a price twice that of a standard medical textile. For context, imagine a medical textile containing an antimicrobial technology that prevents a $20,000 infection. Then, of course it’s worth the 100 percent premium. But from a clinical perspective, how would you find causation between the textile and preventing the infection?
It is very difficult. The industry should take a common-sense approach and use medical textiles that are cost-effective, but also have the technologies that could prevent the spread of infection.
TW: What are the regulatory requirements for medical textiles, and how does this affect marketing?
Wagner：医疗纺织品属于EPA和美国食品药品监督管理局（FDA）管辖权。这是一种称为双重管辖权的情况。从商业纺织的角度来看，这是一个EPA问题。它属于EPA的联邦杀虫剂，杀菌剂和啮齿动物法案（FIFRA）及其农药登记（PR）公告2000-1。但是从医学纺织品的角度来看，如果提供抗菌性能，则可以将磨砂膏视为医疗装置。通过EPA和FDA导航重叠的司法管辖区和管理规则可能是一条艰难的道路。发射抗菌医学纺织品的公司必须确保活跃成分已被EPA批准用于纺织品，并且在FDA指南下还可以接受作为医疗设备的修饰符。
TW: How is Gelest BIOSAFE HM4100 antimicrobial different from other antimicrobials used in medical textiles? How does it work?
Wagner: There was an existing silane quat antimicrobial which was invented and commercialized in the 1970s. Unfortunately, it was flammable and poisonous. The company Biosafe worked with this material, and in the process invented a newer version.
我们通过将现有的单体聚合成干粉来找到我们的利基市场。这种新型的HM4100抗菌干粉可以用塑料复合，溶于水，用作表面处理，甚至旋转成人造纤维。现有技术的应用广度大大扩展了生物安全抗微生物粉的能力，可以去除较旧的基于甲醇的溶液的挥发性有机化合物，易燃性和有毒方面。
生物安全的作用方式是在物理上破坏细胞膜。相比之下，传统的杀菌剂通过从内而外中毒而起作用。大多数老式的杀菌剂基于重金属或氯化酚，并从纺织品中浸出。它们由微生物代谢。当有足够的毒药在微生物内部积聚时，它会导致DNA和细胞裂解的致命突变。不幸的是，这种行动方式也会导致自适应生物，或者在医疗保健环境中众所周知，超级细菌。由于生物安全是非渗透的，并且没有被微生物代谢，因此没有任何传递到细胞，并且微生物没有机会适应这种作用方式。
TW：以哪种形式可用于纺织品生产，哪些好处可为医疗纺织品制造商提供什么好处？
Wagner：它可作为干粉或水或溶剂中的液体使用。生物安全材料可以直接旋转到纤维上，用于纤维饰面方法，也可以用作成品纺织品的处理。聚合物硅氧烷的氢键和共价键合能力使其成为治疗纺织品的理想选择。
有竞争力,医疗纺织品制造商ust address the ongoing concern about the role of healthcare apparel and other healthcare textiles in transmitting pathogens. Biosafe antimicrobial offers medical textile manufacturers the ability to address these concerns.
TW: What kind of toxicity testing is necessary to prove the safety of an antimicrobial, and how did Biosafe perform when tested according to these protocols?
Wagner: Before a textile company uses an active antimicrobial, the active must be approved through the U.S. EPA FIFRA for use on textiles and apparel. The antimicrobial must pass a series of six acute toxicity tests. Companies can go beyond this protocol and also conduct biocompatibility testing under ISO 10993.
Biosafe showed no negative effects in any of the acute toxicity tests. It also is considered biocompatible under ISO cytotoxicity, systemic toxicity, and intracutaneous toxicity. Further, Biosafe has been subjected to the 48 day repeat insult patch test (RIPT) and a mutagenicity test. There were no untoward effects, and the results are available upon request.
TW: What trends do you see shaping the future of medical textiles regarding antimicrobial properties and other key requirements?
Wagner: Medical textiles are considered personal protective equipment (PPE) and play a major role in protecting healthcare workers from transmissible pathogens. Recent literature1 clearly illustrates that healthcare textiles can be a vector for transmission of germs. The trends that will shape the future of the medical textile industry will be technologies than can enable textiles to reduce the acquisition, retention, and transmission of infectious microorganisms found in blood, bodily fluids, and the environment. Gelest’s Biosafe antimicrobial is a very small part of a medical textile. The market is large and the demands are for low-cost, high-performance products. If Gelest delivers powerful antimicrobial technologies at a competitive price, then we have done our job.
1 A. Mitchell et al. / Journal of Hospital Infection (2015) 1e8
May/June 2018
