Viant Medical has signed a consent order to stop sterilizing medical devices using ethylene oxide (EtO) at its plant in Grand Rapids, Mich. by Dec. 31, 2020, according to the Michigan Department of Environment, Great Lakes, and Energy (EGLE).
Viant also agreed to stop using ethylene oxide (EtO) at the plant by Jan. 31, to conduct monthly air sampling through February 2020, and to pay a penalty of $110,000. The consent order stemmed from EGLE’s contention that Viant had allowed excess emissions of the sterilant gas, a known carcinogen that has been linked, in some people, to specific types of cancers when exposed to high levels over a long period of time.
Viant admitted no wrongdoing and the cessation of EtO sterilization was expected. In a letter dated March 4, Viant told nearby residents that it would close the plant by the end of 2019 because “that work is not part of our core business.”
Medplast changed its name to Viant in July 2018 after it acquired Integer’s advanced surgical and orthopedics products lines for $600 million in cash. Medplast acquired the plant in 2015, and only 12 of its 450 employees in Grand Rapids work there, the company letter said.
The Viant plant sterilizes 46 types of devices, including catheters and surgical mesh, according to the FDA. The February shutdown of a major Sterigenics EtO plant in Willowbrook, Ill. prompted the first in a series of FDA warnings about possible device shortages. Two other shutdowns followed in Georgia (one has since reopened), but state and local scrutiny of EtO emissions and public outcry may lead to what one industry advocate called a “rolling effect” of plant shutdowns and device shortages nationwide.
EtO sterilization works at low temperatures — between 90°F and 135°F — making it a viable option for devices made of multiple components and materials, including plastics, polymers, metals and glass, as well as coatings, bonds and packaging from damage. It can also penetrate different types of device packaging, enabling sterilizers to process truckloads’ worth of devices simultaneously.
Viant had self-reported an ethylene oxide leak to the Michigan Department of Environmental Quality (now EGLE) in 2017. The department issued a violation to Viant then and another following a state inspection in November 2018.
EGLE said in a statement that it has been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions at the Grand Rapids plant. Testing found ethylene oxide emissions higher than state and federal health protective levels, the agency said. The violations led to an escalated enforcement action by EGLE against Viant and the subsequent consent order, which was signed Nov. 26.
Viant did not immediately respond to a request for comment on the consent order and plant closure. The order and responses to comments on the order can be found here.
