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FDA, EPA Take Action Against EtO Emissions

 
• By Hannah Daniel

The EPA issued proposed regulations that would limit the use of EtO the same day the FDA launched a pilot program for alternative sterilization methods for medical devices.

• Source: Shutterstock

The US Environmental Protection Agency has released new proposed limits for ethylene oxide (EtO) emissions from medical device sterilizers.

The first proposed rule would require all 86 commercial EtO sterilizers in the US to decrease emissions by 80%, which would comply with pollution controls laid out in the Clean Air

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FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

Brooklyn Medtech Works To Bring Hospital-Level Care To Remote Areas

 
• By Elizabeth Orr

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 
• By Elizabeth Orr and Sue Sutter

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

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FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.