Biofilms are all around us in the OR environment. It takes a team approach to combat biofilm formation. Stronger together? Microorganisms think so too. In a strategy to survive, microorganisms form a protective barrier linked together to make biofilm communities. Most devices used in surgery provide the perfect sanctuary for developing biofilm formation. These surface areas are readily colonized by microorganisms that strongly bind to them. They waste no time reproducing and growing complex biofilm structures within the surgical devices.
When biofilms are formed, they become more resilient to stress. Biofilm formation will resist high-level disinfection and sterilization if the formation is not countered with manual precleaning steps. The more time the biofilm is left without interruption to the reproduction process, the deeper the cell levels can build when precleaning measures are not taken. The risk increases for biofilm disinfectant resistance, further compounding issues. This risk occurs as the disinfectant will only penetrate the biofilm’s outer level, leaving inner levels untouched and able to build up resistance to the disinfectant.
Sterilization similarly only sterilizes the surface, failing to reach past the outer shell of the biofilm. This limited sterilization leaves portions of the biofilm, allowing intact microorganisms on the surgical instrument, even following mechanical washing and the sterilization process, to reach the sterile field, causing infections.
Extracellular glue
Biofilm thrives on wet surfaces. When microorganisms encounter a wet surface, they attach themselves to the surface by producing an extracellular polymeric substance (EPS). The EPS is a gooey substance made up of sugars, proteins, and nucleic acids, similar to DNA. These ingredients are the glue that allows other microorganisms to bind together to form biofilms. A growth period begins as microorganisms bind together, forming a complex biofilm on a surface area.
The environment’s conditions determine the degree to which the biofilm develops. This development can be the difference between a single layer of cells or multiple levels. Environmental stress can stop and slow the development of biofilms. The biofilm’s access to nutrients, an increased amount of water movement, and a lack of oxygen can impede the reproduction of biofilm—time matters in impeding the formation of biofilms. The OR staff and sterile processing technicians are critical in disturbing the biofilm process of producing EPS.
The key to biofilm prevention is precleaning. The Centers for Disease Control and Prevention (CDC) and the Association for the Advancement of Medical Instrumentation (AAMI) have set instrument cleaning and transportation guidelines. Guidelines are further broken down to reflect the unique characteristics of surgical instruments in the manufacturer’s instructions for use (IFU).
Point-of-use cleaning
Point-of-use cleaning is vital for all instruments. It is particularly critical for laparoscopic instruments to combat biofilm formation. Instruments must be monitored during and after the procedure to limit biofilm growth. Laparoscopic instrumentation includes handheld, robotic, and specialty cameras that are complex in design.
They often require special handling procedures due to their delicate nature. During the surgical procedure, flushing and wiping down instruments is critical to keeping the instruments free of bioburden that can build up into biofilm colonies. Lumen instruments must be flushed with sterile water throughout the procedure to remove gross soil and blood. Taking steps to continually preclean during the procedure reduces the biofilm build-up within lumen instruments, rendering subsequent disinfection and sterilization processes effective.
Following the surgical procedure, soiled devices should be prepared for transport to the decontamination area for immediate cleaning. The OR technician is responsible for sorting and disassembling instruments. Specialty instruments require the disassembly of delicate parts. The number of pieces that need to be disassembled can vary. Disassembling instrumentation is critical in preventing biofilm, as it allows cleaning agents to reach all parts of the instrument where biofilm can develop.
Maintain moisture to hinder growth
At no point should the instrumentation be allowed to dry, which makes cleaning the device more difficult. Soaking the instruments with a solution, such as an enzymatic solution, will hinder biofilm growth. The IFU will specify how to keep various instruments moist during transport and the type of liquid solution used to maintain moisture during transport.
Manual cleaning begins with point-of-use cleaning. Manual cleaning continues with instruments that enter the sterile processing decontamination area. In some instances, due to the delicate nature of the device, the manual cleaning performed here will be the final cleaning process to remove biofilms before disinfection, sterilization, and patient use. It is critical to follow each step of the instrument’s IFU for specifics on cleaning chemicals, the correct use, and the type of brushes, in addition to other cleaning steps necessary to remove bioburden.
Following manual cleaning, it is essential to thoroughly rinse with clean water to remove cleaning chemicals and debris. It is imperative to refer to the IFU because some instruments can’t be submerged. Specialty instrumentation can vary in its cleaning process requirements to effectively remove bioburden and biofilm. While some specialty instrumentation can only undergo manual cleaning, some require a combination of manual and mechanical cleaning procedures.
Mechanical cleaning process
The mechanical process of cleaning specialty instruments will vary depending on the IFU. In many cases, mechanical cleaning cannot be performed until the manual cleaning and soaking processes are completed, as mechanical cleaning alone is ineffective in removing biofilm. Before undertaking the mechanical cleaning process, it is necessary to review the IFU.
Some specialty instruments cannot undergo mechanical cleaning, which risks damaging the instruments’ optical surfaces. Mechanical cleaning can include adapters within the machines that allow for automated washing of lumens, further reaching complex locations that harbor biofilm. While shorter mechanical cycles might be available, it is only appropriate to select the amount specified by the IFU. Failure to meet IFU requirements will result in biofilm growth.
Quality assurance is performed in assembly as a final check to ensure no bioburden is present on the instrument. Specialty instruments can be visually inspected by sterile processing technicians for biofilm that escaped the decontamination process.
Inspection is critical
Magnification allows sterile processing personnel to inspect for visual soil in lumens, jointed areas, and serrations on the jaws. Devices can be inserted into lumens to inspect for biofilm—testing for protein. Hemoglobin or organic material can also confirm the presence of biofilm, requiring the device to be returned for decontamination.
Sterilization and disinfection are only achievable if instrumentation is adequately cleaned of biofilm. It is critical to follow the IFU. Each specialty instrument has an IFU that consists of the steps necessary to clean and disinfect or sterilize the surgical instrument to render it safe for patient use. The IFU is a requirement of the US Food & Drug Administration (FDA).
The IFU not only consists of reprocessing instructions detailing the cleaning, disinfection, and sterilization of reusable medical devices, it must prove in worse-case scenarios that the cleaning process can be validated to eliminate bioburden. ANSI/AAMI ST79:2017 states that the current written IFU should be accessible, reviewed, and followed. With adequate time and competency following the IFU, specialty instruments will be free of biofilm and effectively prepared for sterilization.
Biofilm might be more robust together when given the time to form colonies. However, the individuals on the front lines of reprocessing these critical surgical devices are stronger together as they take the steps necessary to eliminate bioburden, rendering them safe for our patients. Following the IFU’s critical steps and established best practices is the road map to success with bioburden busting.