When it comes to tackling the question of single vs. double sterile barrier systems it made the most sense to start with the source, Medical Device Manufacturers (MDMs). At the end of the day, it comes down to what the customer needs and wants, so why not start there? We spoke with packaging engineers at MDMs across various market segments.
According to our research, single barrier packaging is preferred by MDMs and considered the go to for industry packaging.
“If we don’t see an issue or complaint with a single barrier and have good data, then no need to do any of the rest of the product line in anything but a single pouch.” - MDM Packaging Engineer
Therefore, our focus here is on the pros and cons specific to double sterile barrier systems and why a company might select to use one.
When asked about the origin of double sterile barrier systems, the answer was consistent—there was no knowledge of where it specifically started but that many assume people believe it to be an added layer of protection— in other words, a second shot at getting the aseptic transfer right. But not all MDMs agree that it can actually be looked at this way. With a double sterile barrier system, some believe if one part is damaged (inner or outer layer), you really shouldn’t proceed. This contradicts the thought that a double sterile barrier system will provide more protection.
“Even in the sterile field there is still particulate from things like gauze, etc. So, in my opinion, you really don’t have a second layer of protection. It’s a perception and preference, not a must.” - MDM Packaging Engineer
Many voiced that in high-risk procedures where the patient is highly prone to complications, the second sterile barrier system gives you more confidence that the product is safe from contamination until the physician is ready. We also heard doctors and nurses voice this perspective when we spoke with them as well.
Across all MDM discussions, it was clear that double sterile barrier systems tend to appear more in high risk or more expensive devices. Two areas shared consistently were implants and orthopedics. This is where we started to see some differing opinions on the level of protection a double sterile barrier provides.
“A class 3 device is a good example because the sterile needs are super high. It is like a diamond that goes in the heart – you simply can’t afford to drop it. Double barrier systems give a peace of mind that if we drop something we can still use it.” - MDM Packaging Engineer
Other factors that weigh into an MDMs decision to use a double sterile barrier system or not were things like the project manager’s preference, how conservative the company or engineer is, or environmental concerns like temperature and humidity where there is a need for a Tyvek® inner pouch and a foil outer. Regional preferences also came into play. Europe and Japan were two regions that were consistently cited for preferring a double sterile barrier pouch, and in some cases, it was believed that certain hospitals required this from the packaging.
Lastly, there is also the preference of the nurses and doctors to consider. What I generally heard from MDMs was, if you ask a leading question like… “which one do you prefer?”, or show the end user the double barrier, the answer was always double barrier. They believe the aseptic transfer is easier, and sometimes, that is actually true. But MDMs also found if you don’t approach it with a leading question and educate, doctors and nurses were more open to single barrier and understood that it was just as safe. This approach allows the MDM to really make the choice based on the device itself, using the double barrier where it is truly a usability need and adds value.
“I’ve experienced showing them (nurses) samples and walking through usability studies where nurses can’t tell the difference between single and double, and they usually end up being surprised and convinced that single barrier is acceptable for their hospital.” - MDM Packaging Engineer
To the question, where does the double sterile barrier get challenged most? The answer was simple, sustainability.