Sterigenics, an international company who provides sterilization solutions for medical devices, pharmaceutical, commercial, and food industries, has shut down its plant in Willowbrook, Illinois. The recent shutdown, which took place in February 2019, was linked to the discovered release of ethylene oxide emissions which are highly carcinogenic chemicals that are known to sterilize medical devices and other products. The U.S Environmental Protection Agency states, “studies show that breathing air containing elevated ethylene oxide levels over many years increases the risk of some types of cancers, including cancers of the white blood cells (such as non-Hodgkin’s lymphoma, myeloma and lymphocytic leukemia); and breast cancer in females.”
According to Medical Design & Outsourcing, the FDA has warned the public of a potential medical device shortage as a result of the plant shutdown. Roughly 90% of the products sterilized at the Sterigenics Willowbrook facility were medical devices and manufacturers of those products will be greatly impacted by this plant shutdown.
Health Canada has issued a clarification notice on what sort of changes to sterilization procedures would require Medical Device Licence (MDL) amendments. According to Emergo, Health Canada has advised that facility changes alone do not warrant a new MDL application submission. However, MDL amendments are required for changes to sterilization procedures, equipment or cycle parameters. MDL amendments are also required for the following:
- Changes that increase bioburden alerts or action levels;
- Changes that introduce organisms more resistant to sterilization effects;
- Device design and material changes that introduce features more difficult to sterilize;
- Changes in density or configuration of a sterilization load;
- Changes to quality control verification and validation processes.
As a result, moving the sterilization facility may result in one or more of the above changes, therefore leading to potential MDL amendments for several medical devices.
If you require assistance complying with medical device regulatory requirements or would like more information on the matter, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.
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