Packaging, supply and logistics
providers, financially and to their reputation. Laura Bix, assistant dean for teaching, learning and academic analytics at the Michigan State University, says whilst huge progress has been made in the prevention of HAIs, much of it has targeted the “low hanging fruit” and put the onus on healthcare providers themselves, who already have their hands full.
“I think healthcare, in general, needs to look at a more engineered approach to make the jobs of those providers easier,” says Bix, who has lead research projects on medical packaging. “One place that tends to be ubiquitous but invisible is packaging. As a result, I don’t think it gets a lot of attention a lot of the time.” It’s an interesting and arguably fair view. After all, huge steps have been taken in the sterilisation of medical devices, but once they pass through the manufacturer’s gates, they’re very much at the mercy of those handling them.
Bix says that although the contents of a package might be sterile, its outside likely isn’t. Anyone wanting to access the contents will need to handle the outside first. It’s an area she and wider academia have begun to give some real thought to. But, she adds, “not wanting to be doom and gloom, I think it’s still left wanting.”
Those human interactions are fast becoming the source of much interest, and not just from academics like Bix. Asked how much of a role packaging plays in helping to prevent HAIs, Broc Couling, principal packaging engineer with Smith and Nephew says: “We play an absolutely huge role.” This is why companies like Smith and Nephew are beginning to consider the end user through research into what’s called the “human factors” of packaging design. Packaging engineers are increasingly welcoming input from end users, now facilitated by the companies they represent. Smith and Nephew is taking the matter seriously, says Couling, even establishing engineers’ human factors groups. “We now have a human factors department; we never had that three, four or five years ago. Now we have an entire department that we work with on assessing them.”
Human factors It’s a shift the industry has not always been willing to take on though, says Bix: “I think historically the packaging industry has seen itself as sort of a commodity player; and I think device manufacturers tend to see it maybe as a necessary evil.” But, she adds, regulators, standards bodies and manufacturers themselves are recognising the role the sector could play in delivering better care. “We’re slowly starting to see [packaging] as more of an integrated piece of the ability to deliver care well, and how it adds value, as opposed to trying to use it to just reduce costs.”
Medical Device Developments /
www.nsmedicaldevices.com
This relatively fresh approach has seen design processes move away from the established formula of bench testing, says Bix. This is supported by Couling’s revelation that companies like his have established business units on human factors, as well as in the integration of multidisciplinary teams. The use of psychology experts, packaging developers and mechanical engineers, to name a few, help facilitate “technology transfers,” says Bix. “This means we can use techniques and methods that maybe aren’t indigenous to the packaging community” she explains. Many will know of human factors engineering (HFE), or usability engineering. Not exclusive to packaging itself, the concept requires consideration be given to how people will use a product; in this case, the product is the packaging – not what’s inside it. Incorrect use has the potential to undo work undertaken to ensure a device is safe and sterile, possibly risking the product’s suitability and ultimately health outcomes of patients it’s intended for.
So, what are these human factors that medical packaging designers should be, and are becoming, more aware of? Couling says often the belief is that surgeons, for example, are the ones accessing a product and interacting with its packaging, when in fact, it’s the likes of nurses or support staff. Not that it makes a difference – if a package is poorly designed it hinders everyone. “We can behave in a myriad of different ways when it comes to packaging,” adds Bix. “We can take a myriad of different approaches to transferring. We can fight with the material, or not fight with the material. We can use our hands in a variety of different ways. There’s so much variability when it comes to biological creatures and human decision-making.” She says her work has highlighted some of the flaws of current validation processes: “We tend to hand things to the people that prepare the room and ask them their opinions. Some of our work suggests that people can like something very much, and say it works very well, but when you objectively evaluate whether or not the device contacted a non-sterile surface, it’s contacting a non-sterile surface. So healthcare providers’ opinions don’t necessarily equate to a system that is functioning in the way it should.”
Usability parameters
This, Bix continues, is particularly apparent when you consider usability from the perspective of ISO definitions, which have three different parameters: efficiency, effectiveness and satisfaction. “When you just ask their opinions, you’re only hitting the satisfaction element. You’re not looking at effectiveness and efficiency. Does the device hit a non-sterile surface, and what kind of resource – time or strength for instance – needs to go into
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