Bioload Doesn't Have to be a Burden
By Becki Harter, CST, CRCST
Sterile processing department (SPD) personnel manage bioburden every day. Bioburden simply refers to the number of microorganisms on a contaminated object, surface, device or instrument. This is also sometimes referred to as bioload. SPD personnel are the first and last links in the infection control process for surgical departments in hospitals, clinics/doctors' offices and freestanding surgery centers. SPDs must adhere to a strict code of processing and re-processing to protect patients from cross contamination and infection.
There are five basic principles in processing that must be followed to effectively protect patients:
- Inspection and cleaning
SPDs have more options to assist in the removal of bioburden. Washer sterilizers and washer decontaminators have made processing and re-processing much easier and more effective. Because timing and turn-around requirements for instruments and medical devices have become more and more critical in healthcare facilities, there is a tendency or temptation to skip the first principle of processing, inspection. This is a very dangerous departure from the best practice. Washer sterilizers and washer decontaminators are very effective in the removal of bioburden consisting of blood, pus, protein and tissue.
Washer sterilizers and washer decontaminators should not, however, replace hands-on physical removal of visible bioburden as the first very critical step in the processing/re-processing of instruments/medical devices. Washers are immediately more effective tools against infection and cross contamination when applied within the five basic principles of processing rather than used to skip steps. Routine deviation from the basic principles can create negative results in the patient-care delivery system.
One concern that is getting more attention is the development of biofilms on instruments/medical devices or within instruments that have channels or long, hard-to-reach ports, crevices or device designs that cannot be taken apart or contain multiple complex contours (i.e., rasp, reamers, broaches or complex endoscopic instruments). A biofilm is a layer of microorganisms that contain a matrix (slim layer), which will form on surfaces that come in contact with water. The incorporation of pathogens in biofilms can protect the pathogen from concentrations of biocides that would otherwise kill or inhibit those organisms freely suspended in water. Biofilms provide a safe haven for organisms, thus creating the potential of cross contamination/infection.
Preventing cross contamination or the development of biofilms is as simple as following these steps:
1. Never deviate from the five principles of processing/re-processing. Physical removal of visible bioburden using pre-soaks, brushes, sonics and specially formulated bio degradation products coupled with the technological advances in bioburden removal systems is the most effective pathway against cross contamination to patients and the development of biofilms on instruments/medical devices. Administrative support of the best practice must be initiated by education from sterile processing and infection control departments and the development of turn-over times that will meet the needs of each patient, surgical department, physician and administrative fiscal concerns.
2. Use decontamination products that break down bioburden, such as enzymes, phenolics and quats.
3. Follow medical device manufacturers' recommendations for cleaning/disinfection of instruments/medical devices to include purchase of special equipment to effectively clean/decontaminate more complex instruments/medical devices (i.e., flushing devices for channeled instruments to include solutions specific to these devices).
4. When choosing instrumentation/medical devices for purchase, consider the following:
- Equipment needed to process/re-process
- Special solutions needed
- Device complexity: can it be disassembled? Flushed? Immersed?
- Number of uses (some devices are semi-disposable)
- Time needed to re-process
- Special sterilization requirements (steam, plasma, EO/ETO, etc.) Can the instrument/medical device be sterilized in a published standard healthcare sterilization cycle?
5. Surgeon preference
Bioburden, biofilms, contamination, cross contamination and infection control present unique challenges to every SPD and healthcare delivery system. The management of these entities does not have to over-burden healthcare professionals if the best practices adhering to the best standards available are employed. If any step in the process is skipped or altered to facilitate a faster turnover of medical devices for re-use the safety of the patient can be demonstratively compromised.
Choosing instruments/medical devices that fit within the standard processing requirements can diminish some of the challenge created by some very complex devices. As new surgical procedures ascend on the horizon of healthcare, new innovative medical devices must be developed to meet those procedural requirements. With strict adherence to the medical device manufacturer's instructions for cleaning and disinfection, the application of the five basic principles of processing, and use of the best bio-degradation solutions and washer decontaminators/washer sterilizers, the burden of bioburden is no longer of any real consequence. Positive patient care outcomes can be achieved with a strong commitment from healthcare professionals including sterile processing personnel, physicians, nurses, management/administration, infection control/risk management departments, medical device manufacturers and regulatory agencies such as the Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI).
The key is to consider the needs of the patient first. Application of basic principles paved by the road of the best practice built on the foundation of the best standard will ensure the safety and effectiveness of a positive patient-care delivery system.
Becki Harter, CST, CRCST, is president and CEO of Indianapolis-based consulting firm Sterilization By Design, Inc.