08 Jan The Importance of Multi-Sourcing
The Illinois EPA issued a seal order on February 15th 2019 to stop ethylene oxide sterilization by Sterigenics at its Willowbrook site. Ethylene oxide is one of several means to sterilize medical devices, particularly ones that are not suited to other means of sterilization such as gamma radiation or autoclaving. The closure affects quite a few medical device manufacturers, who are now unable to get their products sterilized, which means they are not available to end-users. The FDA is doing what it can to help reduce the resulting device shortages and provide life-saving devices where they’re needed.
This situation highlights the importance of multi-sourcing not only components but also services that are critical to delivery of products, including sterilization and even delivery itself.
Device manufacturers know that the sudden unavailability of a component can bring production to a halt as buyers scramble to find alternate parts and engineers scramble to approve them, but unless someone has experienced it before, it may not be as apparent that multiple service providers should be qualified and ready to go at a moment’s notice in case something like the Sterigenics shutdown occurs. Of course, hindsight is 20/20, but prudent device manufacturers will take this as an opportunity to learn from others’ experience and bolster their own processes.
At Realtime, we believe that an ounce of prevention is worth a pound of cure. Our engineers consider things like unavailability of parts and services in our designs and can help your company put itself into a defensible position should a vendor’s products or services become unavailable. Call us at 972 985-9100 today and let our expertise help you design a better medical device!