Sanderson MacLeod

Mark N. Borsari

What is improper medical device sterilization?

Media coverage over the past five years has frequently and clearly shown that improper sterilization of medical devices, scopes, and equipment has the potential to spread life threatening infections in hospitals and medical facilities. More recently, there have been reports of improperly sterilized medical equipment in outpatient facilities, clinics, and doctor’s offices. In other words, the health risks associated with infections from improperly sterilized and cleaned medical devices extends well beyond the traditional hospital environment.

Incidents of infection resulting from improperly cleaned medical equipment have become so serious that the Center for Disease Control (CDC) and the Food and Drug Administration (FDA) have issued an advisory. The recommendations found in the advisory suggest that hospitals, clinics, outpatient facilities and doctor’s offices should conduct regular audits of how their staff cleans, disinfects and sterilizes medical equipment as well as how the medical equipment is stored and handled. Further, the advisories recommend establishing methodologies for handling problematic situations regarding medical device sterilization.

What are the risks associated with improper medical device sterilization?

It’s clear that improperly sterilized and cleaned medical devices pose a serious risk of patient infection, including the possibility of deadly infection. What may not be immediately evident is the secondary risk medical facilities could face by using unsterile equipment, the risk of litigation resulting from medical negligence.

Recent occurrences of improper medical device sterilization.

Recently, a US-based hospital placed more than 9,500 patients at risk for serious infection. The hospital had to notify patients going back more than 6 six years and was placed under the granular scrutiny of the CDC. In another case, a US-based medical facility was inspected by an unbiased third party who found an array of problems and inconsistencies in the hospital’s protocols as they relate to medical device sterilization.

“Incidents of infection resulting from improperly cleaned medical equipment have become so serious that the Center for Disease Control (CDC) and the Food and Drug Administration (FDA) have issued an advisory”

Unfortunately, these are not isolated cases. While it’s not the intent of this article to highlight names, there are many medical facilities that have had equipment sterilization issues and a large percent discovered the problems when patients contracted infections and became ill. While the solutions to the problem of improper sterilization are certainly not easy to implement, they are critical.

By leveraging the right combination of people, procedure and technology, hospitals and medical facilities can dramatically reduce or eliminate equipment sterilization problems.

What can be done to improve medical device sterilization?

So, we now understand the risks associated with improperly sterilized medical equipment and we’ve examined what the outcome can be if equipment remains contaminated. But what are some of the steps that can be taken to improve the sterilization of medical devices?

The CDC and the FDA have a set of recommendations for products and procedures as they relate to medical device cleaning. In those recommendations, a few elements stand out.

“By leveraging the right combination of people, procedure and technology, hospitals and medical facilities can dramatically reduce or eliminate equipment sterilization problems”

First, there is a recommendation that the “retention of debris in reusable medical devices should not happen.” Debris can be retained where there are scratches, fissures or other damage to the medical equipment. Interestingly, low-quality medical cleaning tools can often be the source of scratches and other damage. That’s right, the tools used to clean and sterilize the equipment can actually cause the damage that results in debris retention. In the case of a medical equipment cleaning brush, the takeaway here is that the protective tip on the end of the brush should be smooth and will not separate from the twisted wires that make up the core of the brush.

Further, the FDA is taking steps to advance the science of medical device cleaning and sterilization. Included in this science is the types of cleaning apparatus that are used to clean medical equipment. An important factor that may be considered is the use of anti-microbial fibers in medical device cleaning brushes.