How stricter EtO regs could shape the medtech industry
May 14, 2024
Source: drugdu
79
The Environmental Protection Agency recently implemented new regulations to limit emissions of a common but cancer-causing medical device sterilant, after years of health meetings, lawsuits and debate about how to handle the issue.
Medical device companies will need to comply with new requirements governing ethylene oxide (EtO) emissions, and some device sterilizers are searching for suitable alternatives.
In April, the EPA published a final rule that sets new limits for medical device sterilizers that use EtO. Now, companies will have three years to comply with the new standards. The agency is also working on a separate set of requirements to reduce EtO exposure for workers in sterilization plants. Long-term exposure to the chemical can increase a person’s lifetime cancer risk.
In the meantime, the Food and Drug Administration has been evaluating other ways of sterilizing medical devices and changes companies can make to reduce EtO emissions. It has also launched programs to make it easier for companies to switch sterilization modalities for devices already on the market.
Source:
https://www.medtechdive.com/news/roundup-ethylene-oxide-sterilizers-medical-device/715783/
Copyright©2024 Ddu. All rights reserved.
Read more on
- Novo Nordisk applies for listing of growth hormone in China once a week September 7, 2024
- Domestic neural device giant sprints for IPO September 7, 2024
- Novo Nordisk applies for listing of growth hormone in China once a week September 7, 2024
- Hengrui Pharmaceutical’s JAK1 inhibitor new indication application for market launch September 7, 2024
- Hainan Free Trade Harbor Drugs, Medical Equipment to Enjoy “zero Tariffs” September 7, 2024
your submission has already been received.
OK
Subscribe
Please enter a valid Email address！
Submit
The most relevant industry news & insight will be sent to you every two weeks.
