Multinational
Berkley Life Sciences offers comprehensive multinational life sciences insurance solutions through our integrated international...
Package
Created by life sciences insurance specialists, our comprehensive life sciences insurance package and workers compensation...
Excess
Commercial excess insurance adds a layer of protection to your business. Our life sciences specialists can help protect against...
Helpline
If you have an active Berkley Life Sciences' policy, you're eligible for up to 2 hours of free legal consultation from one of...
Meet Our Team
Our dedicated life sciences professionals have a deep understanding of unique challenges faced by biotechnology, pharmaceuticals...
Report a Claim
Need to report a claim? Our claims team at Berkley Life Sciences combines proactive collaboration and specialized expertise to...
Primary
Berkley Life Sciences offers primary life sciences Product Liability and Errors and Omissions (E&O) insurance coverage in...
Our Products
We offer comprehensive life sciences insurance solutions globally through our life sciences specialists and appointed retail and...
Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain

Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).
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