Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives

该机构继续鼓励使用环氧乙烷灭菌替代品

SILVER SPRING, Md., Jan. 8, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP's long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

SILVER SPRING，Md.，2024年1月8日/PRNewswire/--今天，美国食品和药物管理局宣布，它认为汽化过氧化氢（VHP）是医疗器械灭菌的既定方法，认识到VHP具有悠久的安全性和有效性历史。FDA修改了上市前通知（510（k））中无菌信息的最终指导，提交和审查，以将VHP列为已建立的A类灭菌方法的一个例子。

This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency's multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency's efforts to advance medical device supply chain resiliency..

这一更新将促进VHP作为医疗器械行业灭菌方法的广泛采用，是该机构多管齐下减少环氧乙烷（EtO）使用的方法的一部分，并进一步支持该机构提高医疗器械供应链弹性的努力。。

Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must not damage devices. For many devices marketed as sterile, a premarket submission must contain information sufficient to show the sterilization process is effective and consistent with internationally accepted consensus standard(s) that the FDA has recognized..

有效的灭菌过程对于某些设备的安全是必要的，因为灭菌会灭活或杀死潜在的有害微生物。除了有效灭活或杀死潜在有害微生物外，灭菌过程不得损坏设备。对于许多以无菌方式销售的设备，上市前提交的材料必须包含足以证明灭菌过程有效且符合FDA认可的国际公认共识标准的信息。。

EtO is the most commonly used sterilization method for medical devices in the U.S., with more than 20 billion devices sold in the U.S. every year sterilized with EtO, accounting for approximately 50% of devices that require sterilization. Since 2019, the FDA has promoted the development of alternatives to EtO and has implemented a number of programs and initiatives to support innovation in medical device sterilization.

EtO是美国最常用的医疗器械灭菌方法，每年在美国销售的器械超过200亿件，约占需要灭菌器械的50%。自2019年以来，FDA促进了EtO替代品的开发，并实施了多项计划和举措，以支持医疗器械灭菌创新。

This includes developing Sterilization Master File Pilot programs to support certain changes to sterilization processes, launching innovation challenges to encourage new strategies to reduce EtO emissions and the development of new sterilization methods or technologies and proactively engaging with industry to help advance innovative alternatives to EtO..

这包括制定灭菌主文件试点计划以支持灭菌过程的某些变化，发起创新挑战以鼓励减少EtO排放的新策略和开发新的灭菌方法或技术，并积极与行业合作，帮助推进EtO的创新替代方案。。

'The FDA's commitment is to protect public health, a critical mission in today's complex medical device ecosystem,' said Suzanne Schwartz, M.D., M.B.A., director of the Office of Strategic Partnerships and Technology Innovation in the FDA's Center for Devices and Radiological Health. 'Vaporized hydrogen peroxide's addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages.

美国食品和药物管理局设备与放射健康中心战略合作与技术创新办公室主任、医学博士苏珊娜·施瓦茨（SuzanneSchwartz）说，美国食品和药物管理局的承诺是保护公众健康，这是当今复杂的医疗器械生态系统中的一项关键任务汽化过氧化氢的添加作为一种既定的灭菌方法，有助于我们为灭菌设备建立更具弹性的供应链，从而有助于防止医疗设备短缺。

As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.'.

随着消毒创新的推进，FDA将继续寻求其他方式，提供安全有效的消毒方法，以最好地保护公众健康。”。

Methods with a long history of safe and effective use on medical devices are considered Established Category A sterilization methods and include moist heat, dry heat, EtO and radiation. With the recent FDA recognition of the ISO standard 22441:2022, the FDA is adding VHP to Established Category A, which the agency expects will strengthen industry's capacity to adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate..

在医疗器械上安全有效使用历史悠久的方法被认为是已建立的a类灭菌方法，包括湿热，干热，EtO和辐射。随着美国食品和药物管理局最近对ISO标准22441:2022的认可，美国食品和药物管理局正在将VHP添加到既定的A类中，该机构预计这将加强行业采用替代灭菌工艺的能力，从而减少对环境和社区的潜在风险。。

The FDA remains committed to reducing adverse impacts to the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon.

FDA仍然致力于减少对环境和公共健康的不利影响，并开发解决方案，以避免美国公众依赖的设备可能短缺。

Additional Resources:

其他资源：

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

在医疗器械上市前提交中适当使用自愿共识标准

Sterilization for Medical Devices

医疗器械灭菌

Media Contact: Audra Harrison, 301-908-6101 Consumer Inquiries: 888-INFO-FDA

媒体联系人：Audra Harrison，301-908-6101消费者咨询：888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products..

美国食品和药物管理局（FDA）是美国卫生与公众服务部（U.S.Department of Health and Human Services）的一个机构，它通过确保人类和兽药、疫苗和其他人类使用的生物制品以及医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、辐射电子产品的安全和安保，并负责监管烟草产品。。

SOURCE U.S. Food and Drug Administration

来源：美国食品和药物管理局