I am the sterile processing manager for the Clinics and Surgery Center located on the University of Minnesota Medical Center Campus. It's a 342,000-square-foot, 10-OR facility that opened in February using nothing but sterile wrap to store sterilized instruments. Yes, I'm talking about tearable, rippable, puncturable sterile wrap. Here's why I stand by that decision.
In the rigid-versus-wrap debate, we hear so much about the holes that can befall the latter. But in my experience I was a surgical technician for 3 years before spending the last 6 in sterile processing problems with sealed containers are the ones that most interrupt work flow.
In the surgical trenches, I often saw containers mismatched with their inner, equipment-holding baskets, which obviously creates a holdup in the OR. Or else arrows the plastic indicators that signal whether a container has been sterilized would go missing. Like socks from a dryer, load stickers indicating date and time of sterilization could mysteriously disappear as well. And retention plates, which hold a filter in place, sometimes came loose. Some of these issues come down to human error. Others are the result of sealed containers getting knocked around in transport. During my time working with these devices, issues were flagged in 5% of cases. That's way too many.
Would you rather fly cross country in a prop plane, or a jet? Using sterilization wrap to keep instruments from contamination is like doing the former. It may get the job done. But using sealed sterilization containers? That's the first-class experience. I am the sterile processing manager at Cleveland Clinic at Marymount Hospital. Of our instrument trays, around 1,000 (or 50%) are containerized. But like all 8 regional hospitals in this network (all of which have between 8 and 16 ORs), and like our main campus (100 ORs), we're incorporating more containers all the time. I am confident this is a move that will might as well say it diminish hospital turbulence.
Fear of change
While sealed sterilization containers have been on the market for more than 30 years, they are still the newer option (some may even say "newfangled"), and some people will avoid working with a tool simply because it is different than what they're used to. Many of my peers feel this way. I get it change can be scary. But what's even scarier is overlooking flaws in the old standby equipment.
While the wrap and sealed options have a lot in common they have the same shelf life, and both include chemical indicators that denote a clean tray there's one major difference: Sterilization wrap punctures. It can easily get snagged on corners when an instrument tray is slid off a rack, for example. And tape can break when someone is moving quickly an occupational necessity and mishandles a tray. While some professionals will tell you these pitfalls can be avoided simply by putting the right process in place, I don't know of any process that removes the hole issue, well, wholly.
Exacerbating the problem, sealed containers take up a great deal more space than sterile wrap about 11???2 times as much, by the time you get everything assembled. And as technology advances, surgeons are only going to require more instrumentation. This doesn't just create a storage issue; it creates a decontamination backlog every time several surgeries finish at once. Sealed containers each add 4 relatively large pieces to a washer: the container itself, which can be as big as 30-by-18 inches, the lid, and a square or circular filter retention plate, which varies in size, depending on brand, and consists of 2 pieces.
It gets worse: Once a washing is complete and you've reassembled and inspected that container, the better part of an hour has gone by. Compare this to the 3 or so minutes it takes to wrap a tray of instruments, and the amount of manpower saved by sterile wrap is clear.
As for price, I have seen many ROIs arguing for containers and against them, and for sterile wrap and against it. Sealed containers have a higher upfront cost and additional preventative maintenance costs. Still, some people insist you'll end up paying more for sterile wrap over the course of many years. The bottom line is this: A price is only as good as the product itself, its implementation and the people who oversee those procedures.
While all of these points are matters of efficiency, the real argument is one of safety. A study conducted by Harry Shaffer, MS, and published in the December 2015 American Journal of Infection Control (osmag.net/xvok6b) found sterilization wrap provided greater protection against airborne bacterial ingress, compared with rigid containers. The study, which was funded by Halyard Health, found bacterial contamination in 87% of rigid containers, some of which had never even been used. Of 161 wrapped trays tested, none demonstrated bacterial ingress into the tray.
In the study, Dr. Shaffer calls rigid containers "complex devices with multiple seals and filters held by retention plates or valves that can be damaged, and demonstrate loss of performance with age and use. Our results indicate that the barrier efficacy of rigid containers may diminish over time."
On the other hand, most sealed containers are made of an aluminum alloy, so tearing isn't a factor. Sure, you may see a broken lock occasionally, but these instances are few and far between. In fact, whenever we encounter a contaminated tray, 95% of the time it's a wrapped tray that's the culprit. And I know first-hand how much a sterility issue can hold up a surgery. Over the course of my 40-year healthcare career, I've worked as a corpsman in the Navy, assisting in surgery while deployed in Okinawa; an OR tech; an organ transplant technician; and a physician assistant.
Plus, sterilization wrap leaves a lot of lint behind, which unless you're a fan of dust bunnies is just plain annoying.
It's no secret that sealed containers are the greener option. But I don't say this only because they last for 15 or 20 years and, therefore, eliminate the waste of single-use wrap something that's only going to become more important moving forward. I say this because certain sealed containers can help you save on resources as well.
Consider steam sterilization. When your equipment (containerized or not) goes through this process, it usually needs to undergo exposure time (in which it's doused with steam), and dry time (in which the instruments are cooled, so condensation doesn't build after hitting the outside air). But with the sealed container we use, dry time isn't required at all, so you end up saving on electricity.
Peace of mind
If all this makes you wonder whether selecting sterile wrap is simply a matter of choosing the lesser of two evils, that's not the case. The point is not that sealed containers are a poor choice and sterile wrap barely edges out the alternative. Sterile wrap is an asset all on its own as long as it's handled correctly. Yes, rips and tears are an issue, but they often happen while a tray is in transport. And while there are hundreds of transport carriers on the market, we chose the one that makes it so we never have to touch a tray from the time it's been wrapped to the time it's delivered to the OR. And a tray you don't have to touch is a tray that stays sterile.
Here's how our one-piece flow system works. We place the wrapped tray on a silicone mat, which keeps it from sliding around during transport. Then, we place the tray and mat on top of a stainless steel carrier, which is about 12-by-24 inches and looks like an oven rack. On each end of this carrier is a hole, about 2-by-4 inches, for putting your fingers through. This lets you pick up the carrier without disturbing the tray or its contents. Using these holes, we lift the whole thing up and place it on a stainless steel transport cart, which looks like a baker's rack. We can fit about 12 carriers here, each on its own shelf, so that no tray touches any other tray. When it's time, we wheel the cart to the OR.
This is a whole new concept, and it's working. In 9 months, we've encountered only 3 holes in our wrap, which works out to be a relatively negligible percentage. (Typically, holes might occur in 2 to 3% of total cases.)
I've worked at a level-one trauma unit, a large offsite processing center and now this ambulatory setting, and this process could work in every situation I've experienced.
Another check in the sterile wrap column is the continuing evolution of sterile wrap material. As recently as 2008, I was using wrap made of muslin. Now, it's a flexible polyester blend that improves barrier effectiveness, and generally makes the wrapping process easier (read: no tangled arms). Within the last 5 years, we've also seen reinforced corners, since these are the areas most susceptible to damage.
Even with these advancements, however, the psychological element remains because they are sturdier, sealed containers are perceived as less vulnerable to contamination. And even though this is a factually inaccurate belief the aforementioned study that found so much bacteria in rigid containers didn't find any on sterile wrapped trays it's understandable. Metal just seems like it'd be a bigger deterrent to a microscopic bug than cloth.
It gives my staff a true sense of security knowing they're delivering a sterile tray to the OR. We don't have to worry about preventative maintenance or arrows dropping or plates loosening or anything else we just have to care for our trays. We do this, and we can be confident. With the right process, there's not much opportunity for things to go wrong.
No system is perfect. There are compelling arguments on the other side. Sterile wrap is not as environmentally friendly as reusable containers. And what about microscopic tears in sterile wrap easily missed by the naked eye? Although multi-colored layers now make spotting even tiny rips easier, this is a valid question. But put all of these factors in play and still, what it comes down to for me is this: What's going to have the best outcome for the patient? OSM
Something else containers can save you: time. While your reprocessing techs have to spend the same amount of time inspecting instruments and reading count sheets to determine which instruments are required for a specific tray, wrapping that tray involves tucking and taping. You're looking at 90 seconds for full assembly. With a sealed container, all you need to do is close a lid and lock 15 or 20 seconds. It may not sound like that big of a difference, but this adds up over the course of a 8-hour shift. Some people will balk at this, because they're really, really good at wrapping. But I'd invite them to stand side by side with a peer assembling a container any day.
For these reasons, the higher upfront cost of a container is worth it. Depending on size, they can range from $150 to $3,000, and yes, that's a lot. But in the long run, what you're paying for is better efficiency, and it's hard to put a price on that.
The bottom line
OK, I'll admit it even I'm on Team Wrap sometimes. Take the storage issue, for example. Wrap takes up less real estate, no way around it. It's a major reason more facilities aren't becoming 100% sealed container. Also, you need to be mindful of size if you don't pick a sealed container that's the proper height for holding, say, ringed instruments, you can end up forcing the lid down, and this doesn't allow for proper sterilization.
And I won't pretend that you don't have to do your research to determine which manufacturer works for you. I took hot coffee and poured it over various rigid containers with sterile instruments inside, and let it sit there for 3 hours, to see which brand held up best. Some worked better than others.
Even so, sealed containers are the better option. Even die-hard wrap enthusiasts will see it that way, once they give today's new sealed container systems a shot. All it takes is an open mind. OSM