The Centers for Disease Control and Prevention (CDC) estimates that HAIs account for an estimated 1.7 million infections and 99,000 associated deaths each year. The picture in Europe is equally miserable; according to the European Centre of Disease Control, some 8.9 million HAIs develop on a yearly basis in European hospitals and long-term care facilities, resulting in 37,000 deaths.
It’s important to note that these staggering statistics are likely not totally accurate; they are, at best, estimates that could be challenged. But they do illustrate the severity of the problem – and this is in the developed world. In May 2022, the WHO reported that out of every 100 patients in acute care hospitals, seven in high-income countries and 15 in low and middle-income countries acquire at least one HAI during their stay – with one in 10 of those patients dying from the infection.
Low hanging fruit
The cost to human health is devastating to those involved; but there is also a cost to healthcare 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.”
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 opening [the packaging] and making the transfer?”
It’s because of this, in part at least, that the FDA released guidance on the issue of human interactions back in 2016, and has updated it since too. The guidance was developed to assist the industry in following appropriate human factors and usability engineering processes to maximise the likelihood that new medical devices are safe and effective, and to minimise potential use errors that can result in harm.
Couling believes the guidance caused a snowball effect for device manufacturers and their packaging teams. Until recently, he says, few included packaging as part of their validation process, including the aseptic presentation part of it. “But I think that’s where we’re heading,” he adds. “When we’re in the ideation phase – not even close to any type of validation verification – we’re getting feedback from surgeons that’s starting to incorporate packaging within it.”
For some time now, there has been criticism that device packaging is too often considered at the wrong part of the design process – the end. Couling agrees this has been the case, but he’s confident this is changing. He says packaging development is a long process, meaning there’s no reason it has to be considered at the latter stages. In fact, it can prove a critical part of a device’s development in itself. “We can release rapid representative prototypes to collect feedback to be able to incorporate packaging, so that we’re not an afterthought,” he says. “I do see it heading that way. The human factors guidance has allowed us to get involved early, and to be able to collect user feedback on their needs early in the development process.”
Stifling innovation is bad for business
The medical device packaging industry is big, and getting bigger still. Growing at around 6.9% annually, it’s set to be worth more than $50bn by the end of the decade. That, if nothing else, illustrates the growing importance many are placing on good, effective solutions. The increasing awareness human interactions with packaging have on the end product will continue to mature – and about time, according to Bix. “It’s a natural evolution of our discipline, and I hope an elevation of it too,” she says. “Because when you just take that basic approach and don’t add value for the end user, you doom yourself to a commodity playing field, where you’re just beating the price out of your product or your package.” This, she warns, is not only bad for healthcare, but it also stifles innovation.
There’s one final thought that Bix shares, and it’s regarding the barriers to traceability when it comes to understanding where HAIs originated – in the US at least. Whether or not an unintended human interaction with a device was the cause of an infection has long been a question. “If you look at independent variables, things that impact outcomes, there’s a real disconnect in terms of being able to identify what all the factors are, down to the packaging.”
She argues that until healthcare is awash with data, it will face challenges in defeating HAIs. “Some people may not want that, because maybe they don’t want to be culpable for the infection,” she adds. “But I personally think that we need some kind of consistent electronic health record, where we can look at what’s going into those health outcomes. I think that would drive a lot of improvements in terms of cost and efficiency – but that’s been discussed for years.”
