The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers. Medical Design & Outsourcing asked Dan Fowler of WuXi AppTec about the implications and options for the industry.
MDO: What can medtech manufacturers do to mitigate the impact of the sterilization plant closures?
Fowler: First, they can determine if any of their products have been validated at alternative EO facilities or under another sterilization method, such as radiation. This may provide alternative solutions. Second, they can evaluate whether they manufacture similar products, such as reusable devices, that can meet the same clinical needs and alleviate pressure on their inventory. Finally, they can establish open communications with regulators to develop plans for completing revalidations and discuss how to fast-track the revalidation data submission to a regulatory agency and expedite the regulatory review process.
If going down the path of revalidation, establishing open communication with regulators can help ease the resubmission process. The FDA is evaluating ways to assist device manufacturers with submissions directly related to the Sterigenics Willowbrook, Ill. plant shutdown in an attempt to mitigate shortages to patients.