It’s a Bumpy Road for Medical Devices. How Do You Know They’ll Arrive Safely?
AAMI WG 40 is drafting guidance to ensure the packaging integrity of sterile medical devices during transport — whether they’re delivered via helicopter, van, or dogsled.
At a Glance
- Watch a video of leaders at AAMI, Healthmark, and HSPA discussing the issue of sterile medtech packaging integrity.
- AAMI's TIR 109 draft guidance for medtech package integrity could be completed as soon as year's end; contact AAMI to help.
Manufacturers spend a lot of time, money, and effort to validate that their packaged medical devices are sterile and will remain that way until the point of use. But what happens to that package when it leaves the manufacturer? Or in the case of sterilizing a reusable device, what happens to it when it leaves the sterilization facility or the hospital?
Brian Stallard, director of news and media relations, Association for the Advancement of Medical Instrumentation (AAMI), recently sat down with Ralph Basile, standards corporate executive, Healthmark, and Sue Klacik, clinical educator, Healthcare Sterile Processing Association (HSPA), to discuss AAMI Technical Information Report (TIR) 109. (Video below.)
The document, being developed by the Steam Sterilization Hospital Practices Working Group (WG 40), will define best practices to ensure the packaging integrity of sterile medical devices once they leave the safety of a controlled environment.
Sterile packaging's rocky road.
So what are the dangers that lurk along the highway? According to Klacik, Mother Nature is one of the biggest threats that can render a sterile package “unsterile.” Rain, fog, heat — all of these elements can result in moisture on the package, which translates into contamination. Potholes may also be a concern: Once the package leaves the controlled environment, it may be subject to shock and vibration on public roadways.
Compounding the problem is the distance that sterile medical devices need to travel. Klacik shares that more hospitals are using their space for direct patient care and moving sterile processing outside the building. Additionally, ambulatory care centers are sending their items to the main hospital — sometimes called the mothership — for processing.
Basile says that TIR 109 will serve as a reference document to help manufacturers make more robust packaging, but it will also guide the user with practices to provide better transport for the packaging. In fact, he is already seeing healthcare facilities start to invest in transport vehicles that better protect medical devices.
During discussions, WG 40 members talked about how to send medical devices from one facility to another. Klacik and Basile heard a lot of stories that included the use of taxis, cars, and helicopters. But their favorite involved a more unusual mode of transportation.
“The best was in Canada,” said Klacik. “Sometimes during the winter there are remote hospitals, and they send them by dogsled.”
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