Published in Manufacturing

Closure of Grand Rapids facility fuels concern over medical device shortage

BY Sunday, November 10, 2019 09:00pm

The stoppage of medical device sterilization at a Grand Rapids facility by the end of the year is adding to local and national concerns about the availability of critical health care equipment.

Facilities across the U.S. that use ethylene oxide to sterilize devices like catheters, feeding tubes and surgical kits have closed recently following air pollution concerns over the carcinogenic gas. 

A plant owned by Viant Medical Inc. near downtown Grand Rapids has faced similar scrutiny from the public and state regulators. The company has a tentative agreement with the state Department of Environment, Great Lakes and Energy (EGLE) to stop its sterilization practices using ethylene oxide by Dec. 31. Viant will also pay a $110,000 fine to settle repeated air pollution violations from the plant.

But stopping the use of ethylene oxide for medical device sterilization is leading to widespread concerns about the availability of the critical equipment. Federal regulators say they are tracking the developments at Viant and elsewhere, urging hospitals, health care facilities and device manufacturers to seek alternatives.

At a public hearing in Grand Rapids last month, EGLE officials expressed similar concerns about alternative sites for sending medical devices for sterilization.

“The (Food and Drug Administration) is now saying there’s a shortage of medical device sterilization services because so many businesses are getting out of it,” said Chris Ethridge, a field operations manager in EGLE’s Air Quality Division. “It’s a bit of a concern to us where the equipment is going to go.”

Viant officials did not respond to multiple requests for comment. The company has used ethylene oxide to sterilize medical devices at the Grand Rapids location for nearly 30 years. It is the largest source of ethylene oxide emissions in the state, according to EGLE.

The U.S. Environmental Protection Agency classified ethylene oxide as a known carcinogen in December 2016. The man-made, flammable, colorless gas could increase the risk of developing blood and breast cancers if breathed in over many years. It’s used mostly to make other chemicals and for sterilizing medical equipment.

Ethylene oxide emissions are regulated at the state and federal level. The EPA is currently reviewing Clean Air Act regulations for facilities that emit ethylene oxide. Concerns over the emissions have also led some states to take action against these facilities.

A facility owned by Sterigenics in Willowbrook, Ill. announced last month that it is closing permanently amid lawsuits claiming increased cancer rates among nearby residents. The company blamed the plant’s closure on “inaccurate and unfounded claims regarding Sterigenics and the unstable legislative and regulatory landscape in Illinois.” 

Ethridge said the Sterigenics plant was an alternative option from Grand Rapids for companies to send devices. A facility has temporarily closed in Atlanta, while another facility in Georgia could potentially close.

According to the Food and Drug Administration, more than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, or about half of all devices that require sterilization. Devices made from plastic, metals or glass are likely to be sterilized with ethylene oxide. Forty-six types of devices are sterilized at the Viant plant in Grand Rapids, while nearly 1,000 different devices were sterilized at the Illinois and Atlanta plants, the FDA reports.

Shortage concerns

The FDA said last month that it anticipates a national shortage of certain medical devices without adequate availability of ethylene oxide sterilization, a situation that could “compromise patient care.” 

“In light of continued potential ethylene oxide sterilization facility closures, we are very concerned about the future availability of medical devices and possible medical device shortages,” FDA spokesperson Brittney Manchester said in an email.

Following the Sterigenics plant closure, the board of the Michigan State Medical Society passed a resolution recognizing the “unintended consequence of supply shortages critical for patient care in the state of Michigan.”

“While this was specific to a plant in Illinois, we want to make sure the ethylene oxide sterilization shutdown does not decrease the availability of critical and lifesaving procedures,” said Medical Society spokesperson Kevin McFatridge.

Some large West Michigan health care providers and manufacturers say they aren’t affected by Viant’s agreement and other plant closures. 

Mercy Health does its sterilization in-house and no longer uses ethylene oxide in the process, said spokesperson Amy Rotter. In a statement, Spectrum Health said it does not use the Viant facility for sterilization.

Kalamazoo-based Stryker Corp., a Fortune 500 medical technology company, previously had a “small number” of its products sterilized at the Sterigenics plant in Illinois.

“We have arranged for sterilization of those products to be completed at other locations,” said Stryker spokesperson Jenny Braga. “As a result, we do not expect product disruption.”

Consent order

On Oct. 23, EGLE officials held a public hearing in downtown Grand Rapids on a draft consent order with Viant to settle previous air pollution violations. Elevated levels of ethylene oxide have been tested multiple times at and around the Grand Rapids facility over the past year. 

Following a series of onsite inspections and air pollution monitoring as part of an “escalated enforcement,” the state and Viant agreed in September to settle compliance violations that would end its medical device sterilization processes by Dec. 31. The state will continue monitoring emissions around the plant through February.

Michigan Department of Health and Human Services officials also showed results of a cancer-incidence study into whether exposure to ethylene oxide was affecting cancer rates in the surrounding area, which included portions of Grand Rapids, Walker and Wyoming. While the state saw fewer cases of breast cancer in women than expected, it found a slightly higher number of cases of multiple myeloma than expected in Kent County.

Still, the state can’t say definitively based on research limitations whether the plant caused higher rates of cancer.

The Chicago Tribune reported in July that it took months for state officials and Viant’s neighbors to realize the extent of ethylene oxide pollution after initial findings from the EPA.

Grand Valley State University chemistry professor George McBane helped lead research last winter on the Viant facility’s effect on air quality at the school’s downtown Grand Rapids campus. McBane said measurements showed no increased risk at the campus, which passed an “intervention threshold,” but he added that the state is “right to be concerned” about longtime residents in the area.

“What matters is cumulative exposure, not the maximum amount you’re exposed to at a given moment,” McBane said. “Some (permanent residents) may have been exposed to a little more ethylene oxide than the GVSU downtown campus, but they are exposed much longer and more contiguously.”

While ethylene oxide emissions from the Viant plant are supposed to stop at the end of the year, McBane and state officials say there are ongoing questions about sources of ethylene oxide emissions, which are found prominently across the country. Car emissions, for example, are a likely source.

“It’s not only coming from the sterilization facility,” McBane said

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