FDA braces for medical device shortages: 9 things to know

Alia Paavola - Print  | 

The FDA is taking several steps to help combat medical device shortages after a major medical device sterilization facility closed.

Nine things to know:

1. Earlier this year the Illinois Environmental Protection Agency issued an order to stop contract sterilizer Sterigenics from sterilizing medical products using ethylene oxide.

2. The FDA noted that another contract sterilizer in Grand Rapids, Mich., Viant, also announced that its facility will close later this year after the Michigan Department of Environmental Quality found some quality issues. When asked about the reason for the closure Viant said its sterilization unit was not part of its core business.

3. Both facilities use ethylene oxide gas to sterilize products, ranging from wound dressings to stents and even kits used in routine hospital procedures. However, the environmental effect of using the gas is affecting manufacturer's ability to use the process.

4. Sterigenics uses the ethylene oxide sterilization process on 594 types of devices, while Viant uses the process on 46 types of devices.

5. Medical device manufacturers rely on these sterilization services.

6. To help prevent potential medical device shortages that may arise from the closure of the facility, the FDA is working directly with manufacturers to better understand the devices that were affected and any potential effects of the closures on device distribution to end users, including healthcare facilities and patients.

7. The FDA is encouraging device manufacturers to consider alternative contract sterilizers.

8. The FDA created a website that will serve as a resource on ethylene oxide sterilization and actions taken by the agency. A device shortages mailbox has been created so that any user, patient or organization can notify the FDA if they anticipate a shortage.

9. "Early awareness of a potential shortage enables us to be proactive and develop a plan to mitigate its effects on patient care," the FDA said.

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