ICT turned to members of industry to cultivate suggestions for how to address bioburden and implement best practices for cleaning, disinfection and sterilization of surgical instruments and devices.
What should sterile processing professionals understand about the role bioburden on surgical instruments and medical devices plays in healthcare-acquired infections?
3M: Reduction of bioburden and removal of gross soil by adequate cleaning and rinsing are essential steps in preparing an item for sterilization. Failure to remove all traces of blood, body fluid, and debris could result in undetected bioburden that could result in a patient infection. The following four phases must be accomplished to produce and maintain a sterile product: a consistent system for lowering and limiting bioburden before sterilization; properly preparing items for sterilization; selecting the appropriate sterilization parameters; and establishing and implementing controls to maintain the sterility of sterilized items until they are used.
Advanced Sterilization Products: One of the most important aspects of any sterilization process is the monitoring of the sterilization. This includes administrative monitoring (compliance with policies and procedures), physical monitoring (review of charts, graphs, gauges and printouts), chemical monitoring and the use of a biological indicator (BI) to confirm sterility assurance. The BI is used to test the effectiveness of the sterilization process by assessing its microbial lethality and provides direct evidence that the process conditions are sufficient to kill spores. Use of a BI is recommended by AAMI, AORN and the CDC, and is the most clinically accepted confirmation of the overall lethality of a sterilization process.
Case Medical: It is important to recognize that healthcare acquired infections are preventable by proper cleaning and decontamination of used devices. Cleaning is required to remove all organic soil and bioburden (microorganisms) from soiled devices for further handling and sterilization. Bertha Litski once said, "An instrument used in surgery is as dangerous as a loaded gun." Infection prevention can stop the spread of infection from one patient to another. If items are not clean, sterilants may not penetrate soil and sterilization may not occur. Ineffective cleaning can not only affect the functionality of the reusable device, but can interfere with subsequent sterilization thus increasing the risk of nosocomial infections.
Ecolab Inc.: Sterile processing professionals understand that instrumentation is a primary front for infection prevention because instruments come into contact with body fluids and other matter that could potentially introduce or transmit pathogens to patients. With the complicated configuration of surgical instruments, proper cleaning to remove the wide variety of biological soils that can become trapped in serrated surfaces, hinges and other areas is a fundamental first step in instrument reprocessing. We’ve found the most effective approach consists of mechanical and chemical treatments – the right products and equipment for the individual facility’s needs – and training to ensure staff is following best practices and using products correctly.
Healthmark Industries: Residual bioburden on surgical instruments represent a two-fold risk: cross contamination between patients from direct exposure to dirty instruments and/or the failure to get instruments sterile because micro-organisms are shielded from the sterilant; and shortening the useful life of surgical instruments through corrosion, build-up of material in hinges, lumens, etc.
Medivators: Bioburden on medical devices can be a causative agent for healthcare-acquired infections in two ways:
- Even if the microorganisms in the bioburden are dead/inactive, they and any other organic/biological soils remaining on the device prevent the cleaning agent and disinfectant from contacting all the surfaces on or in the device. All bioburden must be removed from the device or instrument to ensure effective decontamination.
- If the bioburden contains a viable biofilm mass, the organisms in the biofilm can be sloughed off the device at the time of use, potentially causing a healthcare-acquired infection. Biofilm is a complex entity consisting of various species of bacteria, as well as fungi. It develops in layers or time, so every layer must be removed to eliminate it as a source of potential infection.
Olympus America Inc.: Infection prevention is enhanced when soiled surgical instruments are correctly and appropriately reprocessed and medical devices are thoroughly cleaned. Thorough cleaning is essential before high-level disinfection and sterilization because materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Remaining bioburden can interfere with complete sterilization and presents a potential risk to subsequent patients. Foreign material remaining on an instrument becomes a foreign body inside the next patient and will stimulate the patient’s defense mechanism to either reject or wall off this substance. This then will result in a surgical site infection. SSIs continue to cause morbidity and mortality among surgical patients.
Ruhof Healthcare: Just because a surgical instrument may look clean, it doesn’t necessarily mean it is. Residual bioburden left on an instrument after cleaning can be so miniscule that it can’t be detected by the human eye. Bioburden can also be hidden in the box locks and joints as well as the inside channels of cannulated instruments. Any amount of contamination, no matter how small, poses a serious threat that can lead to the spread of HAIs. It is important not only do a very thorough visual inspection after cleaning, but to also have another more accurate way to test for microbial contamination such as the new ATP testing systems.
Spectrum Surgical Instruments Corp: Bioburden presents a severe risk to patient safety. Always remember, "If it’s not clean it’s not sterile."
- All bioburden must be removed during the decontamination process using the proper cleaning brushes and instrument care solutions.
- Remaining bioburden can lead to instrument malfunction including cracking, staining and stiffness.
- If bioburden is discovered in prep and pack (clean side) of SPD, the instrument must be returned to decontamination process.
SPSmedical: Bioburden that is not removed from reusable medical devices can cause surgical site infections (SSIs). And while SSIs are not considered the leading cause of healthcare acquired infections (HAIs), they are one of the documented causes and HAIs are attributed to causing thousands of deaths each year. To quote a pioneer of infection control who is no longer with us, Dr. Bertha Litsky, "A nonsterile instrument in the OR is like a loaded gun."
