We know that many of you are concerned about the global Coronavirus (COVID-19) outbreak and its impact on your Omnipod® System supplies. Keeping our Podders safe is of utmost importance to us, and we want to reassure you that we're actively monitoring and managing the situation. Here are some answers to some common questions.
1- How is Insulet responding to the Coronavirus outbreak?
A: Insulet continues to vigilantly monitor and manage the global impact of the Coronavirus outbreak and we do not anticipate any product supply issues at this time. We have contingency plans in place and have built inventory and redundancy throughout our supply chain that is designed to mitigate against any supply shortages. Our global manufacturing facilities are running and producing Pods. In addition, our automated manufacturing facility in the U.S. is providing redundancy, risk mitigation, and additional capacity.
We also have a comprehensive plan in place to ensure the safety and well-being of our employees. We will continue to deliver our Omnipod® System to the those who depend on our product to manage their diabetes.
2- Is the Coronavirus impacting Insulet’s ability to produce its products?
A: At this time, Insulet does not anticipate any product supply issues and will continue to deliver our Pods to those who depend on our product to manage their diabetes without any delays. We have systematic contingency plans in place and as part of our standard policy, we have built inventory and redundancy throughout our supply chain, all designed to mitigate against any supply shortages.
3- What sterilization procedures are in place to ensure Pods are safe?
A: Pods are manufactured in a controlled, clean room with proper gowning requirements and environmental controls to ensure the appropriate level of lethality and no unwanted micro-organisms.
After the products are manufactured, they are sent for terminal sterilization either in the U.S. or Belgium. The validated Ethylene Oxide (EO) Sterilization process reliably and consistently sterilizes Insulet products using a 100% Ethylene Oxide (EO) sterilization process that delivers a minimum Sterility Assurance Level (SAL) of 10-6.
Every sterilization load is then tested with biological indicators (BI’s) at an external certified lab, to confirm the lethality of the sterilization process. Based on Insulet’s manufacturing and sterilization processes, we are able to ensure the sterility of each Pod.