Vendors Share Sterile Processing-Related 'Horror Stories'


Infection Control Today invited companies to submit examples of egregious practices witnessed in sterile processing departments in healthcare facilities across the U.S., to highlight techniques needing improvement.

Bob Marrs, BA, CRCST, CHL, director of consulting services/field operations for Aesculap, explains that many facilities are incapable of following manufacturers' IFUs (instructions for use) due to inadequate quantities and or quality of equipment in decontamination, both mechanical equipment and loaner trays. "Often hospitals do not posses a three-basin sink that is recommended in AAMI ST:79," Marrs adds. "These basins are dedicated for soaking, washing and rinsing. The majority of manufacturers' IFUs require all three steps in the cleaning and decontamination process and facilities that do not have a three-basin sink cannot meet this requirement. After manual cleaning, manufacturers often require placing loaner trays in an ultrasonic for cleaning. Ultrasonic cleaning is vital to the cleaning process because of its ability to pull debris out of very difficult-to-clean areas."

Marrs continues, "There are three issues related to ultrasonic cleaners that can turn this saga into a horror story. First, the facility does not own an ultrasonic. Second, the facility owns an ultrasonic and it does not work. Third, the ultrasonic is not utilized according to the manufacturers' IFU; for example, a factory setting of 4 minutes when the manufacturer of the loaner tray requires 10 minutes of ultrasonic cleaning time. All three issues place  hospitals in a very serious predicament."

Marrs points to a persistent lack of resources as a contributing factor to improper processes: "Due to an inadequate amount of mechanical washers, CSP staff are often forced to cut corners to try and keep up with this tremendous burden of trays. Washer decontaminators can be either poorly maintained or are altered to make room for more trays. This is a very dangerous practice because we know that if a device is not clean, it cannot be sterilized. It is vital that a facility follow the washer/decontaminators' IFU for proper decontamination of loaner trays. During sterilization audits, it can be found that washers where shelves or sprayer arms have been removed to make room for more loaner trays. There may also be washers that are missing sprayer arms, sprayer arms that are so clogged that that can not perform in the way that they were designed, and broken of missing sprayer arm bushings that result in the arms not rotating properly. Also, because of backlogs of these sets, CSP staff are not taking apart multi-level trays or leave the lid on the tray going through the washers. Again, this is defeating the purpose of mechanical cleaning because this impedes the water and detergent from reaching the devices."

Marrs adds, "Finally, in an effort to save money, the manufacturers of loaner trays often do not provide an adequate amount of loaner trays to facilities in order to provide the same level of care to each patient. This again places the facility in a very tough predicament because they are either forced to cut corners in the cleaning, decontamination, and sterilization process, or they must delay surgical cases. Facilities must be diligent in following the manufacturers IFUs to ensure that they are providing the best care possible for their patients."

Marrs makes the following suggestions for improvement:
1. Facilities should work to ensure that they have a three-basin sink in the decontamination area.
2. Facilities should have an operational, properly functioning, ultrasonic cleaner in the decontamination area and the IFUs for the ultrasonic and loaner trays should be followed.
3. Facilities should follow the washer/decontaminators' IFU for proper preventive maintenance checks. The washers should also be loaded properly to ensure proper decontamination.
4. Facilities should develop policies and procedures that require the manufacturers of loaner trays to provide an adequate amount of instrument trays to provide the same level of care to every patient.


Improperly loaded sterilizer. Photo courtesy of Aesculap


Sprayer arm is missing. Photo courtesy of Aesculap


Clogged sprayer arm. Photo courtesy of Aesculap


Marcia Frieze, CEO of Case Medical, Inc. says her company endorses best practices including thorough decontamination of all medical devices, and limited use of immediate use sterilization (IUS). "Many facilities adhere to these practices; nonetheless, some staff are routinely 'flashing' and only rinsing eye instruments in basins with high-purity water," Frieze says. "They claim that based on information from certified experts that only water should be used. It is their belief that detergents, especially multi-enzymatic cleaners, cause TASS, an inflammation of the eye that can lead to blindness."

Frieze continues, "Included in Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments from the American Society of Cataract and Refractive Surgery, is a statement that all debris inclusive of OVD be removed with detergent and water, followed by a thorough rinse. Agitation in a basin should not be used in the final rinse. Rinsing should be provided flow of water over and through the device. Some surgery centers are now installing small RO water systems at the rinse sink to address the requirement that high purity water with continuous flow be used. Our concern about cleaning also extends to the factory-based 'fast cycles' programmed in automated washers. Cycles have been reduced to 30 minutes with limited dry time and 15 minutes with no dry time at all. As a result contact time with cleaners may be less than 1 minute and the rinse about 15 seconds. Cool tap water used to avoid the time to pre-heat. This may suffice, provided all previous steps including manual cleaning and disassembling of devices are followed. However in practice, this can have serious implications if washers are overloaded, if rinsing is not adequate and if drying does not occur. Often, sterilization containers for IUS and certain low temperature sterilization cycles are simply wiped down with disinfecting chemicals and germicides. Cleaning with detergent and water, thorough rinsing and drying are critical steps in the decontamination of all surgical devices including eye instrumentation and containers, trays and inserts used for reusable packaging of surgical devices." 


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