Package and Product Integrity Blog

In an ever changing regulatory environment for medical device manufacturers and vendors to the medical device industry, it is extremely important to know how changes are affecting packaging design considerations. Medical device packaging has come under more scrutiny from the FDA in the past few years and is causing MDMs to look closer at the requirements before designing, testing and manufacturing packaging for their medical device products. As a vendor to many medical device companies, it is our priority to monitor and educate ourselves on how the premarket notification process or 510 (k) works.

This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.

Package integrity is specifically mentioned in the FDA guidance documents for 510 (k) approval relating to Submissions for Medical Sterilization Packaging Systems. It is important that manufacturers understand these guidance documents before starting packaging testing, to ensure that time lines will be met and that any failed package validation doesn’t hold up the entire product development process.

Vendors also need to know how the FDA looks at packaging for terminally sterilized medical devices, so that they can have the proper expectations for working with medical device manufacturers.

Here are some of the aspects to consider when designing medical device packaging, in addition to a more strict regulatory environment.

• Meet the needs of all health care practitioners and distributors
• Easy to manufacture
• Comply with increasingly rigorous regulatory requirements
• Protect the sterile integrity of the medical device
• Minimize the impact on the environment

Packaging for medical devices will continue to play an important role in the development of new medical devices. As technology continues to evolve, process for both MDMs and their vendors will need to be clearly defined so that they can maintain positive working relationships. In addition to issues with the regulatory bodies; sustainability, safety, ease of production and meeting the needs of a health care environment that is rapidly changing will be at the forefront of packaging design for medical device products.

What other aspects of medical device packaging need to be addressed in today’s health care environment?