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The Hazards of Flawed Infection Control Studies—for Providers and Patients

Here’s how we are missing the bigger picture in the Sage chlorhexidine wipes debacle.

As we looked into the slippery slope of infection control research and industry funding, an underlying issue comes to light.

Many have drawn attention to the recent concerns over Sage chlorhexidine wipes and their financial backing of several studies. It’s not uncommon for healthcare industry to support research at a hospital level, especially in terms of supporting prominent infectious disease physician endorsement. The issue, though, is that infection prevention and control (IPC) programs throughout the industry often heavily rely on these small trials. Indeed, several of the trials involving the Sage wipes were flawed; however, in an industry desperate for new research and strategies to fight not only healthcare-associated infections but also antibiotic resistance, they spread like wildfire.

The efficacy of the wipes was not the only underlying issue; rather, it was the overzealous claims that led to their widespread use beyond manufacturer recommendations, which have led to negative patient outcomes. Rampant use of chlorhexidine wipes has become indiscriminate in application, which is not surprising given that several of the Sage-backed studies presented them as a wonder product.

Although these recent investigations brought attention to the damaging nature of bias associated with industry funding, perhaps one of the more concerning issues is how desperate IPC programs are to address the issues that seem to be falling on deaf ears.

From antibiotic resistance to the disorganized US Ebola response, infection control has been fighting an up-hill battle for decades. Forcing a product to appear more marketable to solve infection prevention issues—as could be the case of the Sage wipes—is not only dangerous for patients, but it also increases the risk of facilitating antimicrobial resistance. We are at a pivotal point in healthcare and infection prevention in which the normal threats have expanded outside of healthcare-associated infections and microbial resistance. Now, IPC programs have to account for emerging infectious diseases and the growing threat of organisms we once thought of as relatively rare, such as Clostridium difficile. Between C. diff and the Ebola cases in the United States, many programs and manufacturers have realized the range of IPC concerns has broadened.

Products, such Clorox’s new healthcare bleach wipe have adapted to fit this growing range—whether it be C. diff or Ebola, Clorox is one of many companies that has realized the gamut of infection that hospitals and IPC programs have been forced to address.

Intrinsically, what the chlorhexidine and Sage investigation brought to light was the current state of many infection prevention efforts, which are lagging behind, struggling to catch up, and desperately trying to make an existing product fit new threats. The chlorhexidine debacle emphasizes not only the potential for research corruption in infection prevention programs, but also the struggle to bring programs, processes, and products up to date so they may fight today’s problems instead of yesterday’s. Innovation and exploration in healthcare is vital, but it’s crucial that it is legitimate research and not feeble attempts to force a product beyond its scope of utilization. IPC programs and the hospitals they support need to adapt to new infectious disease threats, and demand the same of their products and processes.