FDA Sterilization Innovation Challenge

by | Jul 24, 2019 | FDA, Gene and Cell Therapies, Medical Devices, Pharmaceuticals, Quality Systems, Software

After the shutdown of a major contract sterilization facility in Illinois, and another one in line to close its doors soon, FDA is worried about a shortage of medical devices.

Ethylene Oxide is a widely used sterilization technique for medical products including sutures, surgical mesh, catheters, needles, etc. The Environmental Protection Agencies of Illinois and Michigan found unacceptable levels of EtO emissions around these facilities and issued state orders to stop these sites.

Most of the medical devices require sterilization to reduce the risk of infection caused by these devices in patients. FDA has started two innovation challenges to come up with solutions to deal with the problem of low availability of sterilization contractors. If the solution gets selected, the FDA will work with the applicant to accelerate the development of the technology.1

Challenge # 1:

FDA has challenged the stakeholders to identify innovative sterilization techniques that do not utilize EtO. The goal is that the alternative method is safe and effective to be used on medical devices and compatible with the large cross-section of materials used in the fabrication of medical devices.

Challenge # 2:

FDA’s second challenge is to develop strategies or technologies to reduce the EtO emissions to as low as possible. Innovation strategies may entail changes in the workflow or procedures at the site, changes to the waste processing system of the EtO, etc.

Both challenges are accepting submissions until October 15, 2019. The decisions will be announced between October 16 – November 19.

The submissions should describe the anticipated benefit of the technology, impact of the method or technology on public health, compatibility of the method with medical device materials.

The FDA encourages participation in this challenge from organizations such as sterilization companies, medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations, and other non-profits.

If you would like to submit your ideas to the FDA, visit the following page https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices

Have more questions? Reach out to us at 248-987-4497 or info@emmainternational.com.

1FDA (July 2019) Ethylene Oxide Sterilization for Medical Devices retrieved on 07/18/2019 from https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices


Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

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