CS CONNECTION
Selecting an indicator When evaluating potential indicator technology, Dr. Garrett recommends CS/ SPD professionals ensure the indicator product has the necessary regulatory body approvals (e.g., FDA), meets the intended use of the product within the clinical setting, and has extensive clinical testing data to demonstrate its efficacy. “Finally, the indicator should be cost effective and easy to implement within one’s health system,” Dr. Garrett added. With regards to ease of use, the U.S. Food and Drug Administration (FDA) has raised the issue of CS/SPD team members misinterpreting indicator results because there is no standard indi- cator color to indicate a sterilized device. The agency has urged departments to “enhance staff training on the indicators for all sterilization systems employed in the facility.”5
“Each manufacturer has developed
its own color scheme to validate the sterilization process, and the colors vary among manufacturers even though many are validated for the same cycle condi- tions,” explained Zarembinski. “The FDA is collaborating with manufacturers of sterilization systems to improve product labeling and explore standardization for colors used to indicate sterilization. It’s important to always address the steriliza- tion indicator’s IFU on how to interpret the indicator results.” Hendee stresses the importance of indi- cator compatibility, noting how many indicators on the market are not designed for extended cycles, which are becoming more common in the CS/SPD. He states: “These cycles may be appropriate per the instrument IFU but are they appro- priate per the indicator IFU? Most type 5 chemical indicators and biological indicators are designed to monitor a four-minute sterilization cycle. Because of this, you need to ask yourself, are they appropriate for a longer steriliza- tion time? For example, type 5 indicators react to all critical variables within a cycle. When the critical variable of time changes, shouldn’t the type 5 indicator change as well.”
Education and training As with most aspects of sterile process- ing, sterility and quality assurance goes back to effective staff education and training. Key Surgical Clinical Educator Michelle Lemmons comments on this point, stressing how important it is for
CS/SPD staff members to be able to confidently and independently evaluate effectiveness and have a working knowl- edge of how to troubleshoot issues that they encounter. “It is critical to educate staff on how the equipment works, new products, who to contact if they have questions and WHY each step is needed,” said Lemmons. “Also, providing opportunities for edu- cation and certification advances the sterile processing profession, allows for personal and professional growth of the individual, and increases the visibility of sterile processing’s incredible value to the facility.”
“Best practices for ensuring effective sterilization include a well-trained staff, documenting your processes to verify the requirements are being performed for the task at hand, and auditing your process to see if there are any areas of improve- ment,” Zarembinski added. “Most standards and industry guidelines lay out the baseline expectation for best prac- tices, implementing these into a facility policy along with specific requirements established by the healthcare facility will maximize effective sterilization.” Elammari says she has seen two posi- tive impacts on CS/SPD quality assur- ance recently: the addition of educators and the implementation of huddle boards at shift huddles, stating:
“The addition of educators specific
to SPD has positively impacted the facilities that have implemented this role. They provide staff with resources for additional education and professional growth. Another impact is the use of hud- dle boards during shift huddles. When used correctly, they help close commu- nication gaps, allow staff to speak up and encourage them to take ownership for issues they bring forth. It also allows for discussion concerning essential factors they will face for the day.” Tull points to increased requests from surgeons for vendor trays as a challenge to CS/SPD staff competency, noting how greater in-servicing and training can help boost quality when processing these items. “With the increased use in vendor trays, there is an increased need to have a strong QA process in sterile processing,” Tull commented. “There are so many different companies and systems that staff must be in-serviced so that when performing QA checks knowledge of critical instruments are a must.”
Looking to the future Looking to the future of CS/SPD, Hendee sees a trend towards centralized instru- ment processing. He acknowledges that while this is not a new concept, it is being utilized in more situations than ever before.
“SPDs have been processing (cleaning and sterilizing) instruments for clinics and nursing floors within the facility for decades, but now processing depart- ments are being asked to push this service well beyond those walls,” said Hendee. “While this may help in standardizing processes across the organization, it adds challenges as well. Ensuring quality in a centralized structure will require careful planning, especially around the external transport of these instruments.” Dr. Garrett has seen an increased interest in system-wide sterilization and sterile processing, referencing continued focus by the FDA and infection preven- tion departments on the CS/SPD. In his opinion, greater adoption of automation and monitoring technologies is key to overcoming current challenges in quality and safety. He states:
“Given the high rate of personnel turnover and the growing complexity of reprocessing and sterilization pro- cesses for each device, there is a high potential for human error that exists in the equation. This can lead to cross- contamination of surgical instruments and subsequent potential infection risks to the patient. Innovative automation and monitoring technologies are rapidly entering the medical market and show tremendous promise in optimizing clini- cal workflow, but also in reducing infec- tion risks to patients when all steps in the reprocessing or sterilization process for a device are properly and consistently adhered to.” HPN
References:
1. Processing Change, IAHCSMM,
https://www.iahcsmm.org/ processingchange.html
2. The Joint Commission, New Water Management Require- ments, March 19, 2021,
https://www.jointcommission.org/-/ media/tjc/documents/standards/prepublications/water_man- agement_prepub_hap.pdf
3. Steam Sterilization Standard ST79 Receives Community- Driven Update, AAMI,
https://www.aami.org/detail-pages/ press-release/steam-sterilization-standard-st79-receives-com- munity-driven-update.
4. Mace Davis C, Spear JM. Instrument Set Decontamination Workflows Designed for Success in Sterile Processing. AORN J. 2021 Aug;114(2):149-157. doi: 10.1002/aorn.13468. PMID: 34314002.
5. Risk of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor Sterilization: Letter to Health Care Providers, FDA, May 7, 2020,
https://www.fda.gov/medical-devices/letters- health-care-providers/risk-misinterpreting-hydrogen-peroxide- indicator-colors-vapor-sterilization-letter-health-care.
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