Spinal Medical Devices: Sterile vs. Non-Sterile Packaging Requirements

Implant processing involves FDA regulations, risk, liability, and traceability.  Until recently spinal implants have not been required to implement sterile packaging. Because of this, spinal surgery has an infection rate between 1 – 12%.  These infections not only cause problems for patients, but also for the surgeons and hospitals.  An increase in post-operation infection raises costs for hospitals and diminishes the surgeon’s reputation.

Non-Sterile packaging has shown to be a subpar practice in the medical device industry and has thus led to a change in the packaging requirements.  Proper packaging validation in combination with more sterile requirements, could lower the post-operation infection rate significantly.  Other countries such as Australia have already begun implementing stricter sterile packaging laws.  This change is making their surgeries much safer, therefore lowering the risk and cost for the hospitals and patients!

While this transition to sterile packaging helps the infection rate, it does not fully solve it.  In reality, it will take many years for the non-sterile packages to phase out of hospitals completely.  Spinal devices can be recirculated for many years until they are either used or retired.  This is where the importance of Accelerated Aging Testing comes in.  By ensuring the lifespan of a spinal product, hospitals know exactly when to retire unused devices.  This practice saves lives by avoiding unsterile, outdated, and decaying products from being used in the surgery room.

When considering sterile packaging and accelerated aging, it is also important to consider tests such as Peel Strength, Visual Inspection, Bubble Leak, Dye Leak, and a variety of Transit tests.

Although it will take time, it is easy to understand the importance of this change in the spinal device industry.  As the medical field advances, it is vital to ensure the safety of these devices after they are inputted into the real world transit and hospital environments. Please feel free to extend any questions, comments, or validation quote requests to srosenblum@pkgcompliance.com.