Australian Research Council, Canberra, Australia.
Nanomedicine (Lond). 2010 Jun;5(4):617-32. doi: 10.2217/nnm.10.33.
Silver in nanoparticle form is used extensively worldwide in hospital and general practice settings, in dressings as a treatment for external wounds, burns and ulcers. Nanosilver is also an increasingly important coating over embedded medical devices, inhibiting the development of biofilm. Nanosilver disinfectant sprays and polymer coatings are being widely promoted as protective against viral infections. In addition, nanosilver is widely used for its antibacterial properties in food processing and packaging, as well as in consumer products used for domestic cleaning and clothing. This article argues that medical devices, therapeutic products, and domestic food and goods containing nanosilver, although offering therapeutic benefits, must be subject to precautionary regulation owing to associated public health and environmental risks, particularly from large volumes of nanosilver in waste water. The article first examines the use of nanosilver in a variety of contemporary medical and domestic products, the utilization of which may assist in resolving global public health problems, such as restricted access to safe food, water and medical care. It then discusses the mechanisms of toxicity for nanosilver, whether it should be classified as a new chemical entity for regulatory purposes and whether its increased usage poses significant environmental and public health risks. The article next critically analyses representative international regulatory regimes (the USA, EU, UK and Australia) for medical and domestic use of nanosilver. The conclusion includes a set of recommendations for improving international regulation of nanosilver.
纳米银以颗粒形式在全球范围内被广泛应用于医院和全科诊所，作为治疗外部伤口、烧伤和溃疡的敷料。纳米银也是越来越重要的医疗器械嵌入式涂层，可以抑制生物膜的形成。纳米银消毒剂喷雾和聚合物涂层被广泛推广用于预防病毒感染。此外，纳米银因其在食品加工和包装中的抗菌性能，以及在用于家庭清洁和衣物的消费产品中得到广泛应用。本文认为，尽管含有纳米银的医疗器械、治疗产品和家用食品及商品具有治疗益处，但由于其相关的公共卫生和环境风险，特别是来自废水中大量纳米银，必须受到预防监管。文章首先考察了纳米银在各种当代医疗和家用产品中的应用，这些应用可能有助于解决全球公共卫生问题，如安全食品、水和医疗的获取受限。然后讨论了纳米银的毒性机制，是否应将其归类为新的化学实体以进行监管，以及其使用的增加是否会带来重大的环境和公共卫生风险。文章接下来批判性地分析了具有代表性的国际监管制度（美国、欧盟、英国和澳大利亚）对纳米银的医疗和家用用途的监管。结论包括了一系列关于改进纳米银国际监管的建议。
