Viant to Cease EtO Sterilization in Michigan

Viant Medical signed a consent order to cease ethylene oxide (EtO) sterilization operations at its Grand Rapids, Michigan facility by year-end. During January 2020, the company will use EtO only to calibrate its sterilization chambers to demonstrate that medical equipment, previously treated with EtO, was sterilized in accordance with FDA requirements.

The company will conduct monthly air sampling through February 2020 and will pay a penalty of $110,000 to Michigan’s Department of Environment, Great Lakes and Energy to settle claims of violations of air pollution standards.

If the company fails to comply with various terms of the consent order, it is subject to fines ranging from $500, $5,000 and $10,000 per violation per day.

In its response to this and other site closures, FDA is exploring ways to validate new sterilization agents or processes that don’t come with the same environmental risks while still enabling safe, effective sterilization (and mitigating the effects of product shortages).

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