Cancer risk spurs new push to replace device sterilization technique

Mirroring a push that happened in 2005, the Environmental Protection Agency is once again considering new restrictions on ethylene oxide sterilization due to the risk of cancer posed by emissions — and once again the medical device industry is fighting back, according to an article on WebMD. 

The EPA is considering implementing new regulations to cut back emissions of ethylene oxide because it increases the risk of cancer for those living near the sterilization plants. 

However, the sterilizing and medical device industries are pushing back against the proposed regulations, arguing that restricting ethylene oxide will harm patients. 

The industry, which has spent more than $1 million in the last year lobbying on the issue, said that restricting this method will increase infection risk for patients and lead to device shortages, as more than 50 percent of devices are sterilized using this technique. 

As a result of industry pushback, the EPA has delayed the release of draft regulations on ethylene oxide emissions. The agency announced Sept. 13 that it will not issue a proposed rule on commercial sterilizers immediately and instead will issue an Advance Notice of Proposed Rulemaking and request for information in October. 

This means that an eventual proposed rule on commercial sterilizers will come out in December or January at the earliest, Greg Crist, AdvaMed's chief advocacy officer, told MedTech Dive.

The renewed push mirrors a similar scenario in 2005, when the EPA considered banning ethylene oxide in new sterilizing facilities because of the cancer risk. 

After the industry pushed back and vowed to do everything possible to cut ethylene oxide emissions, the EPA decided not to act, according to WebMD.

Although past experience suggests that the medical device industry may have the upper hand, WebMD reports that there’s a big difference this time around: public awareness.

"Nobody in the last 40 years has been pressuring from the outside that there are community exposures from this," Peter Orris, MD, a professor and chief of occupational and environmental medicine at the University of Illinois at Chicago, told WebMD.

There is now community outcry from residents in Georgia and Illinois who have been exposed to the emissions for decades without knowing it was dangerous, according to the report.

The outrage from exposed communities has lawmakers, health experts and the public pushing regulators to replace ethylene oxide sterilization.

"It is critical that FDA begin investigating alternatives to the EtO sterilization process and prioritize swift adoption of safer methods and substances. Americans should not be forced to choose between sterile medical equipment and increased cancer risks," Democrat senators from Illinois urged in a letter to the FDA, according to WebMD.

As a result of the renewed push, the FDA recently issued a challenge to researchers to explore new ways to sterilize medical devices to reduce dependence on ethylene oxide.

A resolution pending before the American Medical Association board urges physicians to push for substitutes and consider buying medical devices that are most effective for patients, but safer for the environment. 

Read the full report here.

More articles on supply chain:
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FDA warns of more device shortages linked to sterilization plant closure

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