Medical devices are highly regulated and controlled as to their design, safety, uses, and performance. Each component of the device must meet specific standards and go through a range of validations to ensure safety for the end-user.
While not part of the medical device, the packaging also has to go through this rigorous approval process. This includes the use of medical device package testing both in the design phase of the approval process as well as during full-scale production.
There are several different packaging requirements based on the specific type of medical device. All will be required to be packaged in a sterile, non-reusable type of packaging, which is standard for both FDA requirements as well as for devices that will be marketed in other countries including the European Union, which has some of the most demanding packaging requirements.
Why Testing is Critical
Depending on the device, it may be sterilized and then packaged in a sterile packaging process, or it may be sterilized in the packaging using irradiation or other types of methods.
The medical device package testing protocol throughout the packaging process ensures that the sterile environment within the packaging is maintained and not damage due to the treatment or actual physical processing of the package. Without this testing, it would be a possibility that incomplete or damaged seals on blister packs, pouches or other packaging options could let in bacteria or other contaminants that would pose a health risk and potentially the risk of death to the patient.
The use of medical device package testing provides repeatable, verifiable compliance with all packaging requirements for the specific types of device. It also ensures that all packaging from the facility conforms to all applicable regulations and requirements for both devices as well as patient protection and safety.
