All Hands on Deck at FDA to Tackle Ethylene Oxide Shortages

In October the FDA rang a warning bell about a potential nationwide shortage of critical medical devices due to state environmental protection agencies closing facilities in Illinois and Georgia that make ethylene oxide (EtO), the most used gas used to sterilize medical devices in the U.S.

On November 25, 2019, the agency announced two steps the agency is taking to address the expected shortages.

EtO Pilot Program

First, the agency announced an Ethylene Oxide Sterilization Master File Pilot Program (EtO Pilot Program).

This, according to the agency, is a voluntary program intended to allow “sterilization providers that sterilize single-use medical devices using fixed chamber” ethylene oxide to “submit a Master File to the FDA when making certain changes between sterilization sites, or when making certain changes to sterilization processes that utilize reduced EtO concentrations.”

Under this voluntary program, manufacturers (PMA holders) of Class III devices subject to premarket approval that are affected by such changes may reference the Master File submitted by their sterilization provider in a post approval report in lieu of submission of a PMA supplement.

The “…Program seeks to ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health….”

The FDA is seeking participation in the voluntary EtO Pilot Program beginning November 25, 2019. Up to nine eligible participants may be selected for the EtO Pilot Program.

To get more information on how you can participate in this pilot program, click here.

Innovation Challenges

In addition to the pilot program, the agency also announced it had selected 12 participants to work directly with the FDA in “Innovation Challenges.” The challenge is to accelerate the development and review of sterilization technology innovations and reduce EtO emissions to as close to zero as possible.

On July 15, 2019, the FDA announced the innovation challenges to encourage development of novel sterilization methods, was announced back in July. The agency received 46 applications.

Survey of Essential Devices

The agency’s Center for Devices and Radiological Health (CDRH) is also getting into the act with plans to conduct a survey to acquiring and maintaining data on the domestic device inventory, manufacturing capabilities, distribution plans, and raw material constraints “for devices that would be in high demand and/or would be vulnerable to shortages in specific disaster/emergency situations or following specific regulatory actions.”

The FDA said it estimates that about 260 manufacturers will be contacted four times per year either to obtain primary data or to verify/validate data. FDA also estimates that manufacturers will be able to complete each data request in 30 minutes or less.

Advisory Panel Advice

Finally, on November 6-7, 2019, the FDA held a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee meeting to discuss how best to advance innovations in medical device sterilization.

One recommendation from the advisory committee meeting is for device manufacturers to begin, “as soon as possible,” reducing the amount of paper (such as the labeling and instructions for use manuals) that is included in the sterile device package.

Ethylene oxide sterilized medical devices must be sealed in a carefully designed gas-permeable package that enables the ethylene oxide gas to enter. “When the sterilization load (encompassing all the materials inserted into the sterilizer chamber with the device) includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required.”

Because of this, the FDA is encouraging device manufacturers to move to electronic materials where feasible and safe for device users.