Squeaky clean: How to keep up with the rising demand for clean and safe medical devices
Jack Chan, global marketing director - medical, Porex, highlights the potential sterilization challenges medical device manufacturers may face as a result of the rapidly increasing demand for clean and safe devices.
Sterilization is essential to ensure that safe, ready to use devices perform as designed. It is a critical step in the manufacturing process and a medical device is simply not complete without it. Therefore, sterilization needs to be addressed in both the design and material selection phase.
Although manufacturers have always known the importance of sterilization, recent events have driven greater attention to the issue. For one, the Environmental Protection Agency shut down two major Ethylene Oxide (EtO) contract sterilization facilities earlier this year due to high levels of EtO in the air. This is because long-term and occupational exposure to EtO can irritate the eyes, nose, skin, throat and lungs, potentially increasing the risk of cancer. This has caused concern due to a potential shortage of sterilized medical devices and a heightened the demand for clean and safe devices.
Following the closure of the sterilization facilities, the Food and Drug Administration (FDA) issued two public innovation challenges to explore alternatives for using EtO with new sterilization methods and technologies that are effective and environmentally safe. It is equally important to ensure that the medical device’s packaging is designed to protect the medical device and maintain sterility, as well as being able to be validated.
Additionally, as the medical device market continues to grow to meet the demand of the aging population, increasing access to healthcare and rising expectations of innovative devices will dictate a greater need for sterilization. Manufacturers may struggle to manage the increasing sterilization capacity, and it may become impossible to ensure devices are sterile. Microbes cannot be detected by the naked eye and manufacturers cannot ensure that a sterilized medical device that has been transported and stored is still sterile.
It is vital for manufacturers to certify that they are up to date with sterilization standards from the FDA. Manufacturers can also utilize materials in their devices that have been third-party tested and validated as containing virtually no material additives, contaminates or heavy metals that can cause interferences in clinical, analytical and blood transfusion testing, like the certified Pure Porex product lineup.
To provide a solution for these issues and address mounting concerns of potentially life-threatening healthcare-associated infections in China, Porex worked with medical device manufacturer Guangdong Xianfeng Medical Technology to improve the autoclave sterilization process for surgical equipment used within healthcare environments.
Porex provided Xianfeng with a robust, reusable filter that would serve a dual purpose in the medial container:
- To function as a vent to allow pressure equalization during the sterilization process
- To serve as a barrier to bacteria during subsequent storage
Equipped with a Porex Virtek polytetrafluoroethylene solution, the Xianfeng containers can properly sterilize surgical instruments and maintain sterility until use in surgery.