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  1. Medical Devices News and Events

CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization

July 24, 2023

The following is attributed to Suzanne Schwartz, M.D., M.B.A., director, Office of Strategic Partnerships and Technology Innovation, CDRH

Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing additional steps to advance innovation in medical device sterilization. CDRH has updated its Recognized Consensus Standards database to include the complete recognition of one sterilization standard (ISO 22441:2022) and two Technical Information Reports (AAMI TIR104:2022 and AAMI TIR17:2019/(R)2020).

The sterilization standard, ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices, supports the use of low temperature vaporized hydrogen peroxide as an important alternative sterilization method. 

CDRH also recognized two Technical Information Reports associated with medical device sterilization intended to advance device sterilization methods and assist manufacturers making changes to radiation sterilization processes:  AAMI TIR17:2017/(R)2020 Compatibility of materials subjected to sterilization and AAMI TIR104:2022 Guidance on transferring health care products between radiation sterilization sources.

Many manufacturers sterilize their products according to the information provided within voluntary consensus standards, including those for various sterilization processes. When the FDA recognizes standards, it means the FDA finds them acceptable and a manufacturer can make a declaration of conformity to the standards to meet a premarket submission or other requirement. The FDA’s recent recognitions further support supply chain resiliency. 

The Federal Register notice with modifications to the listing of recognized consensus standards for this List 60 will be published later in 2023, although manufacturers may now cite these new and revised standards in device submissions.  

Background on Medical Device Sterilization:

The sterilization of medical devices is a vital process to help prevent serious infections. CDRH remains committed to encouraging novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and to developing solutions that avert potential shortages of devices that the American public relies upon. 

The most commonly used method in the U.S. to sterilize medical devices is ethylene oxide (EtO), and it is widely used by medical device manufacturers and contract sterilizers worldwide. More than 20 billion devices sold in the U.S. every year are sterilized with EtO, accounting for approximately 50% of devices that require sterilization. Inadequate sterilization can lead to life-threatening infections in patients undergoing a wide range of medical procedures. While some innovations appear promising, other methods of sterilization cannot currently replace the use of EtO for many devices.

CDRH continues to oversee sterilization processes for medical devices to ensure they are effective and used in amounts that are safe for the patients and health care professionals who use them. We will continue to work with companies on the development of novel sterilization processes. 

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