FDA Updates Medical Device Sterility Guidelines

Earlier this week, on January 8, 2024, the United States FDA announced a revised version of its guidance on medical device sterility: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

This update revises the guidance to identify vaporized hydrogen peroxide as a category A sterilization method, meaning that it has an established safety and efficacy history and there are standards for development, validation, and control.

The most widely used sterilization method for medical devices is ethylene oxide (EtO). Over 20 billion sterile medical devices are sold in the US annually, adopting EtO sterilization methods. Among all sterilized medical devices, EtO sterilization is used for half.

Despite the widespread use of EtO, the CDC notes that this sterilization process can be lengthy, costly, and potentially hazardous. For example, the compound is an irritant that can impact the skin, eyes, gastrointestinal system, and respiratory tract with acute exposure. Acute exposure can also result in central nervous system depression.

Beyond that, chronic exposure to EtO has been linked to cataracts, cognitive impairment, neurological dysfunction, and other compromising illnesses.

Although EtO sterilization is ideal for sterilizing devices that are sensitive to heat and moisture, adding vaporized hydrogen peroxide to the category A sterilization methods may expand the use of this alternative technique.

“The FDA’s commitment is to protect public health, a critical mission in today’s complex medical device ecosystem,” said Suzanne Schwartz, MD, MBA, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, in the FDA press release. “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. 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.”

Other category A sterilization methods included in the guidance are dry heat, moist heat or steam, and radiation.

In addition, the guidance lists category B sterilization methods, which are established techniques without FDA-recognized standards. That list includes ozone and flexible bag systems.

Finally, the FDA lists some novel sterilization methods such as vaporized peracetic acid, high-intensity light or pulse light, microwave radiation, sound waves, and ultraviolet light.

For each category, the FDA outlines protocols for premarket submissions.