By Douglas McConnell, MD, FACS
By all accounts, Ebola—the disease that has long struck fear in us as images of suffering in sub-Sahara Africa fill our TV screens and movies depict uncontrolled outbreaks—has now become a very real pandemic that is wiping out villages and rapidly crossing borders. As I write this article, the virus has killed nearly 5,000 people with thousands more infected. The United Nations estimates that it will need more than $1 billion to fight the epidemic and President Obama has already begun sending an estimated 4,000 U.S. military personnel and many more military medical staff to train the thousands of healthcare providers who will be needed to care for patients and prevent transmission of the disease.
With the Ebola outbreak igniting fear across the globe and the return of infected American healthcare workers to U.S. cities for treatment, hospitals in this country are tasked with examining what precautions they’re taking to keep the virus contained. In an effort to assist, the Centers for Disease Control (CDC) in August released infection prevention and control guidance for U.S. hospitals treating “known or suspected” Ebola victims. Among their recommendations, the CDC suggests that “dedicated medical equipment (preferably disposable, when possible) should be used for the provision of patient care” and “all non-dedicated, non-disposable medical equipment used for patient care should be cleaned and disinfected according to manufacturer's instructions and hospital policies.”
This all makes perfect sense, but is it enough? What happens if “manufacturer instructions” and existing hospital policies aren’t sufficient to ensure that “cleaned” devices are actually “clean”? What is the risk of cross contamination and what can be done about it?
When Clean Isn’t Really Clean
There is a growing body of evidence—and countless real-world examples—that demonstrate how so-called “disinfected” medical devices are not as clean as we think. Take laryngoscopes for example. A study published in Anesthesia & Analgesia found that of 40 laryngoscope handles taken from the operating rooms of SUNY Upstate Medical University, 75 percent tested positive for bacteria, even when treated with low-level disinfectant. Researchers at the Swansea University School of Medicine published a similar study in the Journal of Hospital Infection, which found that out of 64 laryngoscope handles that had been reprocessed and deemed “ready to use,” 86 percent still had bacteria on them.
That’s the science, and it’s backed up daily by news stories about hospital-acquired infections (HAIs)— the CDC estimates one in every 20 patients gets one—and contamination resulting from improperly sterilized devices.
Part of the problem is that while most laryngoscopes (and other products like it) require single-use components (such as blades), in many cases there are parts (like the handles) that are reprocessed and reused. Even when staff follow manufacturer recommendations for cleaning, contaminants can still exist deep in the equipment because cleaning protocols aren’t sufficient, devices aren’t cleaned fast enough or they simply weren’t designed with optimal cleaning in mind. This also is a perfect example of technology adding to the problem: the more technologically advanced the tool is, the more difficult it can be to clean. Staff cannot simply submerge high tech devices into a cleaning solution without ruining the electronics and tech tools such as an arthroscopic shaver come with many small pieces, making visual inspection impossible.
While the requirements for cleaning devices that come in direct contact with a patient are easy to understand (even if they aren’t always easy to implement), it’s also important to note that FDA cleaning and disinfection validations now extend to products and surfaces that may never come into direct contact with a patient—things like wall mount drug delivery systems, exam room knobs, handles, probe docking stations, carts, cables, touch screens, smartphones, monitors, and even keyboards. These items still pose risks for secondary cross contamination and, again, most are not designed for easy cleaning.
It’s not hard to imagine that if reprocessing doesn’t get a reusable device truly clean—or if potential sources of contamination, such as handles or even plug-in light sources, are overlooked when considering potential risk factors and developing institutional decontamination protocols—that devices, their components and even the seemingly benign items you see in an exam room, all can easily become vehicles for cross contamination.
In the Age of Ebola, Three Things Every Hospital Should Consider
The need to reduce the risk of cross contamination in healthcare settings is always important, but when we’re dealing with a virulent and active infection like Ebola, the need for diligence becomes critical. So in light of the current pandemic, here are a few things hospitals should be thinking about.
Go the Extra Mile with Cleaning
For products that must be reused—and this includes everything from surgical instruments to blood pressure cuffs—make sure to follow all manufacturer recommendations for cleaning. But then go one step further. You need to require that the manufacturers and distributors you work with provide the most extensive cleaning instructions possible customized for your organization. These instructions should take into consideration the sanitizing environment at your facility and how it will affect your ability to effectively clean each device. For example, are you a large hospital with large volumes of devices to clean so products might sit for days before reprocessing? Are your storage and cleaning areas located in the basement of your medical facility where it is inherently dusty and damp? Do the devices you’re reprocessing have parts that are difficult to inspect with the naked eye? All of these factors can affect your best practices for ensuring that a given device is truly “clean” and ready to use on the next patient.
Consider a Move to Single-Use
As the CDC suggests, whenever possible, use disposable products. The reality is that reprocessing of critical devices can be expensive and imperfect. The last 20 years have seen a steady adoption of disposable products as a way to prevent cross contamination (with increased efficiency and cost reduction as nice side benefits). Back when I was a resident, surgical gowns, hats, patient drapes and even procedure trays (and the instruments on them) were reprocessed and sterilized between uses. Today, almost all have been replaced with disposables. When a product is opened, used on a single patient and then thrown out, the risk of cross contamination from one patient to another drops to almost zero.
It’s important to remember, however, that when considering a move from reusable to single-use, it’s not just the device itself that you have to think about. For example, in the case of vaginal speculums, many acute care settings are moving from reusable metal to disposable plastic versions. But these disposable specula often still make use of plug-in or rechargeable light sources that can get dirty and become sources of cross contamination if not properly cleaned. The good news is that some single-use options now on the market actually have built-in light sources. This means that everything, including the light, comes out of the package ready to use and is throw away after a single procedure, eliminating the time and expense of reprocessing and significantly reducing the risk of cross contamination.
Update Your Policies and Protocols
Controlling HAIs and cross contamination is no longer just a serious health issue, it’s also a significant financial one now that healthcare reform legislation ties infection control to Medicare payments. In light of these legislative changes and growing concern over epidemics like Ebola, hospitals need to revisit and ensure that their policies and protocols for cross contamination are updated regularly.
While Ebola has put the spotlight on infection control in an unprecedented way, these are considerations that every healthcare organization should keep top of mind at all times. This discussion should also serve as a positive reminder of how we can use modern technology and materials to help reduce the risk of cross contamination not only in acute situations, but also to address the daily need for greater diligence and enhanced infection control in healthcare settings of every size each.
Douglas H. McConnell, MD, FACS, is medical director at OBP Medical, the leading global developer of single-use, self-contained, illuminating medical devices. Trained at Stanford University and the University of California at Los Angeles (UCLA) School of Medicine, McConnell is board certified in thoracic surgery and currently serves as director of cardiac surgery at Shasta Regional Medical Center, a 246-bed acute care, medical and surgical facility in Northern California.