The Art of Designing for Infection Prevention
By Lise Moloney, director of business development, healthcare, Sciessent
We’ve all read the horror stories about healthcare-associated infections (HAIs) wreaking havoc at hospitals across the U.S. and the globe. Many HAIs, including CRE and MRSA, are caused by antibiotic-resistant organisms and have very high mortality rates. Due to this worldwide crisis, companies across the healthcare continuum are looking for ways to combat these deadly threats with better infection-prevention strategies.
Med-device manufactures are increasingly looking for ways to incorporate antimicrobials onto the surfaces of medical devices – adding yet another layer of protection for patients. Hospitals are also focusing on products that help improve patient care and reduce costs. While embedding antimicrobials into already-designed medical devices is indeed beneficial, there are other infection-prevention strategies that can be employed much earlier in the lifecycle of a product that should be considered.
While there are strategies and proven best practices to help med-device manufacturers design for infection prevention (which we’ll discuss below), one of the most important places to start is educating the design teams. Designers are often far removed from the real-world usage of the products that they are not “in the know” about the risks associated with them.
Manufacturers need to put time and resources into educating their designers from day one on how the product will be used, the risks associated with it and where the path of infection typically starts. They should also share the abundance of clinical data on infection rates and prevention strategies around medical devices. Arming designers with this knowledge will help them create new and redesign existing products for infection prevention – many times in ways that have never been thought of before.
Designing for Easy Cleaning
It’s no surprise that after a reusable device is used it has to be cleaned – first removing the soil from the surface and then sterilizing it with a disinfectant. But if the first part of the process is not done correctly (which can happen due to human error or hard-to-clean areas), the device may not be adequately disinfected due to the remaining soil load and become a source of infection. This is especially true for devices that have rough surfaces, deep groves, hard angles or multiple parts, which hold on to bacteria more often.
When possible, manufacturers should go back to the drawing board (literally) by designing products with smoother surfaces, fewer crevices and curved corners. For devices that have to be disassembled, they should look at ways to ensure easier reassembly and provide custom cleaning tools for hard-to-clean components.
Considering Active vs. Passive Surfaces
Simply put, a passive surface is material that is not particularly used for anything other than being material. An active surface is performing a function. For medical devices, a passive surface is yet another area to worry about being a conduit of infection. In fact, passive materials, including plastics, on many of today’s medical devices actually promote bacterial attachment.
Manufacturers need to incorporate more active surfaces into their products through the use of several tactics. Embedded, controlled-release antimicrobials on the surfaces of devices are proving to have high-kill rates for pathogens, especially antibiotic-resistant organisms. The use of low-attachment hydrophilic surfaces can also be employed, which make it hard for organisms and bodily fluids to adhere to the product. Some manufacturers are even starting to use combined low-attachment/antimicrobial strategies.
Weighing the Disposable Option (if Appropriate)
There are a lot of things to consider, including cost and use time, to determine whether it makes sense to have a disposable device vs. a reusable one. For reusable devices, one strategy used is disposable components – parts that can be thrown away after each use.
A growing number of manufacturers are incorporating disposable components into their reusable devices. One recent example is EKG cables, which were used (and rarely cleaned), patient after patient, and found to be major sources of contamination. Today, manufacturers are providing reusable cables.
It is important to note that despite being disposable, these components can still carry harmful organisms, so incorporating the design and active surface strategies for them, which we described above, should also be considered.
Recognizing that certain medical devices are major causes of some of the most dangerous and hard-to-treat infections is the first part of the battle in helping to eliminate them. Med-device manufacturers need to innovate and change the game for the way products are designed to combat this growing problem. Simple design changes such as the ones noted above can prove vital for reducing infection risks.