Sattar S A
Centre for Research on Environmental Microbiology (CREM), Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
J Appl Microbiol. 2006 Oct;101(4):743-53. doi: 10.1111/j.1365-2672.2006.03128.x.
Microbial pathogens continue as major threats to health. Indeed, many ongoing societal changes are enhancing our vulnerability and exposure to several frank and opportunistic pathogens. This, together with rampant antimicrobial resistance and reduced prospects for newer drugs and vaccines, is forcing a higher reliance on microbiocides in infection prevention and control. That this reliance may not be well-founded becomes apparent from a closer look at current ways of testing and registering microbiocides, their label claims as well as human and environmental safety of certain widely used microbicidal chemicals. Many methods to test microbiocides for registration are flawed and/or entail test conditions irrelevant to field use. Pathogens listed on product labels may not be among those amenable to interruption through microbiocide use. The wide variations and discrepancies in existing national/regional regulations for registering microbiocides for sale stifle innovation. This is a critical look at the above-mentioned issues with emphasis on chemicals meant for use on environmental surfaces and medical devices. It highlights better ways to test microbiocides and to attain global harmonization of testing and product registration. It also details the known and potential dangers of microbiocide use and what to consider in choosing such formulations for optimal safety and effectiveness. End users are advised to be more critical and prudent in the selection and application of microbicidal chemicals, manufacturers are encouraged to explore infection control products and technologies that are safer in the workplace and for the environment, and regulators are urged to review and update the requirements and procedures for premarket review of microbiocide efficacy data and label claims. Independent investigations are also urgently needed to document the proportion of nosocomial infections that would be amenable to prevention through chemical disinfection of environmental surfaces.
微生物病原体仍然是健康的主要威胁。事实上，当前许多社会变革正在增加我们对几种显性和机会性病原体的易感性及接触机会。这一点，再加上猖獗的抗菌药物耐药性以及新型药物和疫苗研发前景的降低，使得在感染预防和控制方面对杀微生物剂的依赖程度更高。通过仔细审视当前杀微生物剂的测试和注册方式、其标签声明以及某些广泛使用的杀微生物化学物质对人类和环境的安全性，就会发现这种依赖可能并无充分依据。许多用于杀微生物剂注册的测试方法存在缺陷和/或涉及与实际使用无关的测试条件。产品标签上列出的病原体可能并非那些可通过使用杀微生物剂来阻断的病原体。现有的国家/地区杀微生物剂销售注册法规存在很大差异和不一致之处，抑制了创新。本文着重审视上述问题，重点关注用于环境表面和医疗设备的化学物质。它强调了更好的杀微生物剂测试方法以及实现全球测试和产品注册协调统一的方法。它还详细阐述了使用杀微生物剂已知的和潜在的危险，以及在选择此类制剂以实现最佳安全性和有效性时应考虑的因素。建议终端用户在选择和应用杀微生物化学物质时更加审慎，鼓励制造商探索在工作场所和环境方面更安全的感染控制产品和技术，并敦促监管机构审查和更新杀微生物剂功效数据和标签声明的上市前审查要求及程序。还迫切需要进行独立调查，以记录可通过对环境表面进行化学消毒预防的医院感染比例。
