EPA to Limit Ethylene Oxide Emissions from Medical Device Sterilizers.
Background
How much do you know about the history of ethylene oxide and the role it has played in medical device sterilization?
Since the inception of its use as an insecticide 160 years ago, Ethylene Oxide (EtO) has been used within the industry across a spectrum of applications, ranging from the manufacture of anti-freeze to the sterilization of medical devices.
EtO is currently the most commonly used method in the U.S. to sterilize medical devices and is widely used by medical device manufacturers and contract sterilizers worldwide. The use of EtO is a well-established and scientifically proven method of preventing harmful microorganisms from reproducing on medical devices and causing infections in patients. Unlike some other sterilization methods, EtO does not degrade the product. Currently, is the only option for a large number of medical devices due to material heat – or moisture sensitivities and/or design complexity.
More than 20 billion devices sold in the U.S. every year are sterilized with EtO, accounting for approximately 50% of devices that require sterilization. These devices range from wound dressings to more specialized devices, such as stents, as well as kits used in routine hospital procedures or surgeries. Inadequate sterilization can lead to life-threatening infections in patients undergoing a wide range of medical procedures. Medical devices are sterilized in the U.S. market using ethylene oxide at about 100 facilities.
EPA New Requirements.
Medical Device sterilizers will face new limits on ethylene oxide emissions and new requirements for worker protections. Companies will have 18 months to install the required pollution controls after the EPA issues a final rule. The proposed rule would seek to bring the concentration of EtO used to sterilize medical devices down to 500 milligrams per liter for each cycle.
The agency also issued a proposed interim decision to increase protections for people working in these facilities and living in nearby communities. Those measures include engineering controls, such as emissions capture technology, to reduce worker exposure, and requiring that staff wear protective equipment when EtO is detected. It would also reduce the amount of EtO that may be applied for medical device sterilization while meeting standards for sterility assurance.
The sterilizers are concerned that 18 months would not be enough time to meet the new emissions monitoring requirements due to the fact that supply chains and manufacturing are still recovering from the pandemic and emission detector equipment may not arrive at the sterilizer within 18 months. It will require investments and innovations to reduce residual emissions.
FDA Announces Radiation Sterilization Master File Pilot Program
FDA starts a device sterilization pilot program to help the industry do adapt to EtO emissions. The U.S. Food and Drug Administration has created a program to help companies adopt new ways to sterilize approved, single-use medical devices. FDA is seeking participation in the voluntary Radiation Pilot Program beginning April 12, 2023.
For more information on the radiation pilot program, see FDA’s website:
Center for Devices and Radiological Health Radiation Sterilization Master File Pilot Program.
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