Industry Addresses Challenges of Bioburden, Offers Best-Practice Advice

May 18, 2011

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. Weve found the most effective approach consists of mechanical and chemical treatments the right products and equipment for the individual facilitys 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 patients 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 doesnt necessarily mean it is. Residual bioburden left on an instrument after cleaning can be so miniscule that it cant 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 its not clean its 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."

What is a best-practice recommendation relating to the decontamination, cleaning, disinfection, sterilization or sterility assurance process?

3M: Healthcare facilities responsible for processing reusable medical devices should establish policies and procedures for all aspects of reprocessing that are based on current standards and recommended practices, such as those from AAMI, AORN and the CDC. Its important that all processes be audited on a regular basis. All aspects of reprocessing should be performed by knowledgeable, trained personnel. Reprocessing should be performed in a centralized area that complies with the physical and human resource requirements for reprocessing. Finally, there needs to be a procedure established for the recall of improperly reprocessed medical equipment and devices.

Advanced Sterilization Products: Sterile processing professionals must ensure that bioburden has been removed from endoscopes prior to disinfection, which can be done manually or through an automated process. Remaining bioburden acts as a barrier and could result in infection transmission. Because manual cleaning is a tedious, time-intensive and error-prone process, an FDA-approved endoscope cleaner and reprocessor (ECR) provides an automated approach superior to manual cleaning (it does not eliminate the need for bedside pre-cleaning). The ECR also performs monitoring of critical parameters so healthcare professionals can be confident they have optimally reprocessed endoscopes and thereby reduced risk for patients.

Case Medical: Always follow manufacturers instructions, because ignoring them might lead to expensive replacement or repairs. Furthermore, incorrect re-processing could cause product failure and endanger the patient or staff. Nearly all medical device manufacturers recommend pH neutral instrument chemistries for re-processing their devices. There are products on the market that demonstrate proven effectiveness while being pH neutral and environmentally safe. Cleaning, decontamination and subsequent sterilization are essential steps in breaking the chain of infection. Manufacturers should be committed to design and produce instrument chemistries with demonstrated efficacy and sustainability.

Ecolab Inc.: There are no magic bullets that can solve every issue in instrument reprocessing but a comprehensive approach that considers the departments current processes, water quality and soil types can identify what products, processes and training need to be implemented to improve outcomes and achieve a consistent level of performance. A good first step is to conduct a baseline assessment to find what sterile processing is struggling with. In many cases, issues such as persistent soils are a result of factors such as water hardness, pH or temperature, or incorrect product use which can be easily solved by adjustments to equipment and chemistry or staff training.

Healthmark Industries: Preventing bioburden, particularly blood, prior to cleaning procedures is absolutely critical. Once dried, proteins and other organics become highly insolvent and very difficult to clean. This is even more true in instruments with lumens, which direct observation of staining is usually not possible. Keeping instruments moist during transportation, and beginning cleaning as soon as possible, is absolutely key.

Medivators: Instruments and medical devices should be reprocessed (cleaned and disinfected/sterilized) as soon as possible after use. If they cant be reprocessed immediately, lumened devices should at least have a detergent solution sucked through the channels, and the exterior of the device wiped with a detergent saturated cloth. Cleaning should be done using a manufacturers recommendations, with fresh detergent solution and rinse water for every device. Manual brushing, if recommended, should be done with a single-use brush, and should be continued until all visible soil has been removed. Disinfection or sterilization of a device is based on the Spaulding classification of that device. In either case, meticulous and thorough cleaning must precede the antimicrobial treatment. Testing of the disinfectant prior to each use (with a test strip) is required, and it must be discarded if past its use life or does not meet MEC requirement.

Metrex Research Corp.: The AAMI Guideline on "Safe Handling and Biological Decontamination of Reusable Medical Devices in Healthcare Facilities and in Non-Clinical Settings" recommend using cleaning products on instruments immediately after use to keep them moist in transport containers.* Allow instruments to remain covered with enzymatic foam to dissolve bioburden. Then place used instruments in a clearly marked decontamination area. Use an enzymatic detergent to pre-clean instruments prior to sterilization or high-level disinfection. When diluting the enzymatic detergent, make sure to follow manufacture labeled dilution instructions. Source: *AAMI Guideline Transportation, section 6.2.

Mobile Instrument Service & Repair: The decontamination and cleaning process begins while the surgical procedure is still underway. Instruments and equipment in use at the operative site should be continually wiped clean of blood and bioburden with a surgical sponge soaked in sterile water. Instruments no longer in use, but still in the sterile field, should be soaked in a basin filled with sterile water. Instruments should never be cleaned or soaked with saline because it can cause corrosion, staining, and eventually, pitting. Blood and bioburden is much more difficult to clean off if allowed to dry. An instrument that is sterilized with residual contaminants will sometimes require professional service in order to remove the resulting stains and prevent pitting.

Olympus America Inc.: Steam sterilization is the most frequently used method of sterilization for reprocessing. It is the preferred method of sterilization for items that are heat and moisture stable. It is also the oldest, safest, most economical and reliable method available. The efficacy depends on lowering the bioburden on instruments by thoroughly cleaning and drying prior to sterilization. Steam leaves no harmful residue and instruments can withstand repeated reprocessing without damage. Ensure all instruments are properly processed and sterilized by dedicating someone to this responsibility. Patient safety is an important measure for all facilities and reprocessing instruments is a key part of ensuring a sterile and safe environment.

Ruhof Healthcare: Having a good sterility assurance policy that is adhered to is extremely important in lowering the risk of HAIs. Being able to verify if your policy is successful is equally as important. A very effective way of doing this is by measuring for adenosine triphosphate (ATP) on surfaces of surgical instruments after cleaning. All organic matter contains the molecule ATP, so if an instrument tests positive for ATP, there is some contamination present that can possibly spread an HAI. Using an ATP testing system (luciferase swab, ATP luminometer and software) can help evaluate and improve your cleaning protocols and allow you to track and document your results.

Spectrum Surgical Instruments Corp.:

Decontamination: The use of proper solutions / soaps, proper brushes, and any required PPE.

Cleaning: The use of an ultrasonic cleaning machine is documented to clean 16 times better than manual cleaning. Ultrasonic cleaning removes hidden bioburden and debris that cant be seen or cleaned during manual cleaning.

Sterilization: Always follow manufacturers guidelines, sterilize instruments with ratchets open to allow proper steam penetration, and to prevent the instrument from cracking.

Sterility assurance: Do not overpack/overload sets, avoid trays with sharp corners that may tear the wrap, use integrators in each set to measure time, temperature and the presence of steam.

SPSmedical: Best practice recommendations for instrument reprocessing can be found in both AAMI and AORN standards. It is critical that healthcare facilities have these documents and reference them in their Policy & Procedures. The most important best practice recommendation is to have and follow each device manufacturers Instructions For Use (IFU). A validated IFU tells you what equipment and supplies are needed to properly reprocess the device. From this information, you can determine if a routine or special procedure (cleaning, packaging, and/or sterilization) is needed. Special procedures also require additional time which is important to know when scheduling procedures and assigning personnel.