Healthcare Hygiene magazine August 2020 | Page 27

“Manufacturers need to know that a certification is coming,” Turner says. “Dig deeper to understand how the healthcare environment is different from other environments. Test aggressively with disinfectants that are commonly used. Pursue a certification to accelerate adoption of new innovative solutions that reduce cost and infection in the long-term for healthcare.” Another potential solution, at least for equipment, UCSF’s Fechter says, is for regulation by the FDA, and including standardized compatibility testing in the agency’s 510k pre-market approval process for equipment and devices. “There is no entity that can mandate the manufacturers to do anything except the FDA,” Fechter says. “So, if we can get this agency to require compatibility testing as part of their process, you might get some traction among the manufacturers. At the rate the FDA does things, I would not bet on that happening any time soon — it is a very slow process.” “We need to better leverage reports of failures from incompatibility,” Fechter adds. “I reported the syringe pumps breaking apart and harming our patients, but that was just one report and that means nothing to them unless they receive hundreds of reports – then maybe they will take action. Fast-forward from that 2004 syringe pump incident to 2010 or so, when one of our other infusion pumps started experiencing problems — and not just in our facility but in a lot of facilities. The door hinges were breaking, potentially allowing medication to flow unregulated into the patient that could result in a serious overdose. The pump manufacturers acknowledged that the door hinges were breaking, and they started their own journey to compatibility. It probably took them more than a year to change their formulation of plastics; they started making the same part out of different material and the new and improved plastic was much more compatible than the previous plastic and drastically reduced the number of door hinge failures. Part by part, the manufacturers had to upgrade other pieces of the pump with new plastics. They didn’t do everything at once, they only re-manufactured the parts that were breaking. It was a dangerous situation that presented serious patient safety-related issues.” Fechter continues, “We have no control over what materials the manufacturers use but can choose from whom to buy. The challenge is that our choices in the marketplace are limited. What we can change is our cleaning products, choosing the ones that are the most compatible with our equipment and surfaces. I conducted testing on different cleaning products to sell our infection control team on the one that I found to be the least destructive. At the time I had estimated that our system was facing at least $2 million worth of broken and failed equipment, and my guess was that the real number was a lot higher than that, but people don’t document these failures in a way that allows you to conduct that analysis accurately. Instead, you walk around the facility, look at how many devices broke and how many are currently disintegrating. You soon discover that a piece of equipment that might last five years is now lasting two years, so we must replace that much more frequently or repair more frequently. Just repairing parts alone can cost an astronomical amount of money.” Fechter looks to manufacturers to better address the problem. “My opinion is that the entities who manufacturer the raw materials know what they are doing, and they are able to present viable options to their customers – the medical device and surface manufacturers,” he says. “Medical device manufacturers often don’t want to spend 20 cents more on a better plastic to make a product more durable, and I suppose they have their reasons as to why they don’t want to use the better-performing polymers. But if you look at the cost of a medical device like an infusion pump, which can run as much as $10,000, and the cost of the raw material for the plastic that goes into making the pump is two or three dollars tops, so as a percentage of the manufacturing cost, that raw material is nothing. Even if they pick a better-performing plastic that is twice as expensive as what they are using, it is insignificant in the total cost of that infusion pump. So, I don’t think they have a lot of excuses.” Desired cosmetic finishes and aesthetics are likely to dictate manufacturers’ decision-making, Fechter adds. “In addition to the look of a product, there may be mechanical properties dictating function over form. Some of the final materials used in the finished product hold up better than others, so you must convince manufacturers to move away from their Some of the final materials used in the finished product hold up better than others, so you must convince manufacturers to move away from their favorite things like polycarbonate and ABS and use more resistant and durable formulas and materials.” favorite things like polycarbonate and ABS and use more resistant and durable formulas and materials. it is going to increase the cost of the product, yes, but not significantly.” “Another aspect of the problem is not just the materials, but the design of the product itself,” Fechter emphasizes. “If you have a flat, smooth surface and you wipe it with disinfectant and it dries off, those flat smooth surfaces tend to not suffer damage. Where you see the damage is in the nooks, crannies, corners, around fasteners or any kinds of seams where the liquid disinfectant seeps into the cracks and crevices and stays wet a lot longer than it would on that flat, smooth surface. From an overall cleaning standpoint, and especially from an infection control perspective, most devices are designed with far too many nooks and crannies that invite body fluids and blood to get sucked in and then contamination persists in these areas that are nearly impossible to clean and disinfect properly. To be fair, we have seen some improvement in recent years with the introduction of more control panels manufactured from flat, smooth glass that so much easier to clean. For example, in the old days, ultrasound machines had a million knobs and switches, and now we are seeing new machines out on the market that have simple glass touchscreens. From a cleaning standpoint, these surfaces are wonderful because there are fewer places for germs to hide, and even a pretty poor disinfectant will address the microorganisms on it. From a user standpoint, some clinicians still say they like the feel of the old-fashioned knobs and buttons, but it is something they’re going to have to get used to, and I don’t think it’s that hard to use a glass touchscreen.” Designing equipment so it is easier to clean is just part of the issue; the benefits of improved device design can be lost if no one actually cleans it. Healthcare facilities have been struggling with ensuring accountability between clinicians and environmental services when it comes to which party is responsible for cleaning and disinfecting patient-care equipment. www.healthcarehygienemagazine.com • august 2020 27