By Kelly M. Pyrek
Manufacturers make claims about their products' efficacy in killing disease-causing pathogens, but what do infection preventionists really know about the validity of these claims? In a series of articles, we'll take a look at what practitioners in infection prevention should understand about the science behind label claims and marketing hype, including the FDA clearance and EPA registration processes, as well as testing protocols that preceded a product's appearance in the marketplace. In this first article, we talk to Wallace Puckett, PhD, vice president of science and technology for STERIS Corporation, about the knowledge gaps that currently exist relating to research and development of disinfectants, antibacterials, antimicrobials, microbicides and sporicides.
Q: Why isn't there more dialogue about the science behind products used to combat healthcare-acquired infections (HAIs) in the healthcare setting?
A: We in the industry many times do not pursue efforts to make educational presentations on the basic science of products at professional meetings and conferences. There are not enough of us talking about what goes on with the science behind these products and technologies currently in the marketplace. Perhaps it's because we have not done a good enough job of convincing professional organizations to set aside time during their meetings for a session on basic science. Another reason is that we in the industry have had a tendency in the past to not have a scientist do the presentations. The industry must do a better job of building a reputation with organizations such as SHEA or IDSA that when we make presentations, they will be free of commercial bias and we are going to be talking about science and technology, not selling a product. And that we are going to avoid making disparaging comments about our competitors and their products and instead focus on educating people on issues in infection control. Scientists should also attend the meetings for infection preventionists, as well as to the meetings for attendees who are actually using our products; the infectious disease physicians rarely make product-purchasing decisions. Having said that, everyone must be informed about the science behind these products.
Q: What should infection preventionists know about the research and development (R&D) being conducted these days?
A: There has been a huge change in the way for-profit companies conduct their R&D activities. There used to be a significant emphasis on the research part of the R&D equation, in part driven by the World War II era when U.S. government officials began to realize we were woefully behind the rest of the world on technology development in general. So a lot of money and effort was expended at the university and corporate levels. In the 1980s, the strategy began to change -- there was much less basic research and far more applications development. What's happening today is that other than the pharmaceutical companies and certain chemical and device manufacturers, we really conduct very limited and focused basic research. We call it R&D but for most companies it's really a very small "R" and a really big "D." These days, it's difficult to put new chemistries, whether they are for hand hygiene or for surface disinfection, on the market. So we spend our time developing new applications for existing active ingredients. It's very difficult to make a business justification for doing the basic research and taking the risk of developing a new active ingredient when the world is full of gaps and opportunities for new applications of these existing active ingredients. Companies like STERIS and other big players in the industry spend much of their time on developing applications of existing technologies and chemicals, leaving it to the university and the government labs as well as the entrepreneurial start-ups to do the high-risk work of new active-ingredient development. We have found ourselves in a race around a few active ingredients to uncover features, benefits or advantages in the products we produce to give ourselves a leg up on the competition.
Q: What has been the primary focus of this applications work lately?
A: We are driven by needs in the marketplace, and recently there has been a big push to help healthcare professionals reduce the time it takes to get a surgical instrument reprocessed -- properly cleaned and sterilized or high level disinfected so it is available for the next procedure. So our emphasis in new product development has been on how we reduce that "skin-to-skin" cycle time, or getting an instrument from one patient to the next patient in a timely fashion while reducing the complexity of that process.
Q: So what's the common reaction to hearing about the science behind the products?
A: The current regulatory climate drives a set of standards for testing, but it's so complex and ever-changing, and that's why when you talk to a healthcare professional about science, many times you see their eyes glaze over. We say our products are tuberculocidal in X minutes or sporicidal in X minutes, and people look at me with a blank stare and they say, "Just tell me if the product works."
Q: But aren't they missing critical information?
A: There are many nuances that are missed when this happens. For example, when you look at a particular active ingredient, the formulation is the most critical component of whether or not that active ingredient is effective or not. You get into things like lipophilicity or cationic compatibility; a difficult concept which can be challenging to understand. Other critical nuances relate to compatibility among antimicrobials. For instance, for surgical site preparation, clinicians might use one kind of soap to clean the surface of the skin and then use a second product that's not compatible with the first . Even though the surgical site prep product was validated to produce a specific reduction of microorganisms on the skin, when it was used with another, incompatible product, the overall effectiveness was diminished because the products were used together unknowingly -- and that important nuance might be lost. So then you have vendors calling on the hospital and saying, "Hey, I've got this great soap you can use to clean the skin before you do your surgical prep." Unfortunately they may not be sophisticated enough to question what surgical site preps the hospital staff is already using. The vendor needs to say, "Because if you are using povidone iodine, I'll sell you this product because it is compatible with povidone iodine; if you are using ChloraPrep, I'm going to sell you another one because it is compatible with that prep." But unfortunately we don't always have that level of critical thinking among vendors.
