Have you ever stopped to consider all the hazards your packaged sterile medical device encounters on its journey from your manufacturing facility until it’s in the hands of a healthcare practitioner?
Your first inclination is probably to say that the primary and secondary packaging for your medical device was designed to maintain package integrity from start to finish. And you may even follow that up by citing transportation simulation testing results and compliance with ISO 11607.
And that’s a good start. But the harsh reality is that the secondary packaging is often discarded early in the journey. Consider what happens at the growing number of healthcare systems that include facilities at multiple locations. Medical devices and supplies are purchased for the entire system and received at a central location where they are removed from the secondary packaging in order to be re-shipped in small quantities to the multiple locations within the system.
That means your packaged sterile medical device will not have the benefit of the secondary packaging that was intended to protect it from multiple distribution hazards such as extreme temperatures and humidity, vibrations, pressure changes, drops, impacts, dust, etc.
When it is finally received at the healthcare facility where it will be used, the journey for your medical device—with its multiple challenges to package integrity—is not yet over. Just take a moment to think about all the potential hazards and environmental factors a packaged sterile medical device might encounter in a healthcare facility. It’s staggering.
So, the question you need to ask yourself is this: “Does my primary packaging have the ability to maintain integrity from start to finish?”
If you specify DuPont™ Tyvek® for your medical packaging, you can rest assured that it will stand up to even the most rigorous conditions—every step of the journey. Tyvek® is the medical packaging material you can count on to deliver sterile, undamaged supplies and devices, time after time.