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Safety Can’t Be Rushed

The task of reprocessing surgical instruments and specialized medical devices requires an intense series of steps that have no room for mistakes or shortcuts. Many specialized devices have multiple components that require disassembly for proper cleaning. Some need specific equipment and time to perform the cleaning process correctly; if the steps are not meticulously followed, cross-contamination can be detrimental to patients. Regulatory, governmental, and accrediting agencies have published guidelines to assist sterile processing (SP) professionals with policies and procedures that protect and ensure patient safety. The COVID-19 pandemic demonstrated that simple cleaning and disinfecting principles could prove effective in eradicating a worldwide virus.

Before COVID-19, we were making progress in getting organizations to understand and follow the CDC HAH 382 recommendation “to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines…and allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturer, including drying, proper storage, and transport of reprocessed devices.”1 It seems that to capture lost time and perhaps lost revenue, we have gone back to the overuse of rapid turnover processes, reinstated frequent immediate use sterilization (IUS), and overlooked the manufacturer’s instructions for use (IFUs) for medical devices.

In my perspective, recent social media posts have raised red flags with hundreds of comments from SP technicians saying their organizations push them to take processing shortcuts to have surgical instruments ready for the following procedure. There are alarming facts that can potentially lead to a compromised tray being sent to the OR and used in a procedure.

Sterile processing professionals must engage in active participation of the OR schedule and voice their concerns that lapses in protocols because of lack of time to complete the process presents significant infection control and patient safety risks. How can an SP technician or manager convey this message to the administration and the OR?

  • We must continue to educate everyone involved in following manufacturers’ IFUs. Medical devices are tested and validated based on the steps written in the IFU. Staff must follow the specific cleaning, sonification, disinfection, inspection, assembly, and sterilization measures. Not following these detailed steps may render an item unsafe.
  • We have always heard, “If it’s not clean, it can’t be sterilized.” If indicated, the instrument disassembly step cannot be rushed or, worse, skipped! Without disassembling the device and completing the proper residual soil tests and inspections, how can we be sure that the medical device we are advancing to the next step is clean?

Reprocessing equipment such as washers, ultrasonic cleaners, sterilizers, etc., have been validated to complete a process in a certain amount of time. 

  • Once the sterilizer chamber door is closed, the process must be completed. Never break a cycle to advance a tray to the next step to save time.
  • Always complete the assembly process. Inspect all items for bioburden, sharpness, and functionality. Finding a critical item broken during the surgical procedure could have a fatal outcome for the patient.
  • Account for everything listed on the count sheet. Make sure the integrator is included and visible when packages are opened. Wrap the tray according to the modality to be used and consistently inspect the final product to ensure no package is compromised during handling. If using rigid sterilization containers, check the integrity of the gasket, retention plates, and latches to ensure there is a tight fit. Never rush this inspection process, as you may forget to include the filters and the tamperproof locks.

Sterilization documentation
Whether we are documenting the sterilization process manually or digitally, the process should be the same. Record all items in the load, and ensure each piece has a lot control number for easy retrieval in the event of process failure. Perform a quality audit on the load to ensure all containers have filters, tamperproof locks, and an indicator card. Inspect each package, and ensure lids are securely positioned on containers. Include a process challenge device in the load.

  • The sterilization process parameters should never be reduced to expedite the cycle and finish faster, and the device IFU must always be followed. Aborting a cycle requires re-wrapping all items in the load and then reprocessing. Using items before a complete sterilization cycle is not permitted.
  • Release and transport sterile packages. It is critically important to let packages cool down after sterilization and before dispensing them. Do not handle sterilized devices while they are hot as “a hand can act as a point of condensation for the warm water vapor emanating from the package, thereby creating a moist area on the outside of the package.”2 Use an infrared thermometer to verify packages have reached room temperature and are ready to be handled.
  • All packages must be cooled before being released for transport. Review the load printout to ensure all cycle parameters were met before releasing the load. A negative biological culture should be obtained according to hospital protocols before releasing the load. Some hospitals using a digitalized system scan all trays into a case cart before they are dispensed. A copy of the case cart contents is attached to the cart to alert the OR about the items included. Review the wrap IFU to ensure trays can be stacked. Rigid containers also have specific recommendations for storage and stacking containers.

There is a legal, moral, and ethical responsibility among every technician to ensure all steps are followed to provide an instrument set that potentially will not harm a patient. Rushing through the process can produce an instrument set with defects that can negatively affect the surgery. Performing each step required by the manufacturer’s instructions for use protects patient safety, the surgeon, the team, and the organization.

Keeping in mind that we have no time to waste, we want to produce the best product we can because we always want to lead to excellence in safety.

References

  1. CDC.gov. “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices,” September 11, 2015, accessed July 1, 2021. https://emergency.cdc.gov/han/han00382.asp
  2. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2017. Section 10.3.1, p. 64.

Mary Olivera, MHA, CRCST, CHL, FCS has over 30 years of experience in numerous roles in healthcare sterile processing, distribution, and materials management. Ms. Olivera participates in monitoring, surveying, and training interdepartmental staff in the proper cleaning, decontamination, and sterilization practices, and has been highly committed to the standardization of interdepartmental processes. A regular recruit on expert panels regarding sterile processing and a past president of the New York State Central Service organization, she continues to play a major role in promoting higher educational requirements for central service professionals to increase patient safety.

Ms. Olivera brings to the table extensive knowledge of Joint Commission, DNV-GL, AAMI, OSHA, CDC, and DoH regulations. She specializes in budgeting, change management, inventory management, process re-engineering, program and project management, vendor relationships, quality control, Six Sigma, supply chain, and total quality management.

Ms. Olivera is an educator and has published numerous articles related to sterile processing, surgical services, process improvement, and guides to achieve successful accreditation surveys.

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