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Ensuring Sufficient Time to Reprocess Instrument Trays

A few years ago, a friend got me interested in golf and it has become one of my spare-time passions. The game requires time, precision, and the right equipment, otherwise the score will reflect the player’s inability to succeed. Depending on the distance to the green and the player’s skill, a club is chosen to tee off the ball. The player must have the right equipment to be able to hit the ball in the direction of the green and not end up out of bounds or in the bunker. It is a game that cannot be rushed; every move must be carefully thought through. A round of golf can take up to four hours, but the ultimate success of the round relies on taking the time and having the right club available for the next play.

Let’s compare the sterile processing department (SPD) processes with a round of golf. We plan for the next day’s surgeries and assess which equipment is needed. At the beginning of the day, technicians and surgeons are ready, but the essential equipment needed to perform the surgical procedure is not available because the sterilizer broke down, and holes or bioburden were found on the tray. The team must wait three hours until the instruments are reprocessed. Everyone gets frustrated and the mood is set for the day.

Unfortunately, this is a frequent scenario in SPDs across the country. Sterile processing departments often prepare for a full OR surgical schedule, but do not have instrumentation to fulfill the demands of the operating room. What are we doing wrong? How can we meet OR demands while providing adequate time to reprocess necessary instrumentation?

According to a health advisory from the CDC, healthcare facilities “should 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. […] Considerations should be made regarding scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing.”1 Yet we struggle to adhere to this recommendation. How can SPDs improve how they serve the operating room? What can the operating room do to help SPDs deliver needed instrumentation on time? A necessary first step toward building a more productive partnership between operating rooms and SPDs is to outline processes and time required to complete each step.


Mary Olivera

Sufficient time to adhere to steps in the Instructions for Use
Manufacturers are required to submit a 510(k) to the Food and Drug Administration (FDA) for a device to be approved for sale in the US. The document must contain all relevant scientific data and microbiology testing results for cleaning and sterilization. The manufacturer must outline steps for cleaning bioburden from the device and then sterilizing the device. These processes must be followed in detail and cannot be altered, even if SPDs are in a rush to meet surgical schedule demands. When we make alterations to the steps or time required for each process, we operate off-label and therefore assume all liability for the outcome.

Is there bioburden?
Many medical devices must be disassembled for cleaning. For example, the IFU for a Storz cystoscope sheath states: “Prior to cleaning and disinfection, the product must be separated into its individual components as far as possible.”2 This is important because debris and bioburden can settle inside very small areas. Similarly, stopcocks also require disassembly for cleaning. The instructions for use (IFU) recommends taking each component apart after use, but often technicians simply flush the stopcock without removing the spring cap and the cock plug. How can we attest a device is bioburden-free if we have not disassembled it during the cleaning process? This is challenging when technicians are rushed to clean devices because the instrument is needed for the next case.

Getting the device sterile
Sterilize it. That may sound simple, but let’s look more closely at what is required to get a medical device or a tray ready for the sterilization process.

  • After the medical device has gone through a rigid cleaning process, it must go through the inspection process to ensure all bioburden has been removed. Best practice would require a residual soil test. This may entail using a swab with a developing solution that is then put into a UV reader. If there is no residue, the device or set can move on to the packaging stage of the process. If it is a tray with multiple soft tissue instruments, then every one of the instruments must be inspected and tested to ensure that they are functioning according to the manufacturer’s specifications.
  • Once the inspection test is completed, we begin to account for every instrument that is supposed to be in the set, according to the predetermined count sheet. If the instruments are complete, we can proceed to wrap the tray. But if there are any missing or broken instruments, we must find replacements before the set is assembled.
  • Preparing the set for sterilization also requires adhering to the following steps accurately. If the set is predetermined to go into a sterilization rigid container, we must inspect the components of the container to ensure a tight fit and sterilization barrier. We inspect the retention plates, lid gasket, and latches to ensure the seal is still within the manufacturer’s specifications. Then we inspect the lid and the container to ensure there is no damage and the lid and bottom provides a proper barrier to the instruments.
  • If we are using disposable wrap, the wrap must be inspected before it is used. We must ensure that the wrap has no holes or damage before the device is wrapped.

Sterilization process; is it too hot?
Once the tray is wrapped and ready for sterilization, we must ensure that there is a sterilizer available for the process. The sterilization technician alerts us about availability. The sterilization cycle takes about 60 minutes, but it depends on the pressure of the hospital steam. Therefore, it is imperative to ensure the steam quality is pure and within the guidelines established by recommended practice, otherwise the cycle may be stagnant and take much longer to finish.

Once the sterilization process is complete, we cannot just take the tray out of the sterilizer and bring it to the OR. We must allow adequate time for cooling, as outlined in the AAMI ST79:10.3.1., “Adequate cooling could require two hours or more, depending on the conditions and package contents.”3 Transporting a package that is hot may cause water vapor to settle in the trays and can draw bacteria into the packages from hands and the environment.

Transport with care
To determine if a package is ready for transport, use an infrared thermometer to verify if the package has reached room temperature, anywhere between 72 and 75 degrees Fahrenheit. Packages must be contained in a closed cart for transportation to maintain sterility.

How long did it take me?
Time flies in the SPD and unless you measure how long each process takes to complete, it may not seem like much time has passed. Each piece of equipment for reprocessing has predetermined cycles that cannot be broken or altered. The same happens with hand cleaning, preparing, inspecting, and sterilizing—steps that we cannot rush or skip. Otherwise, we risk sending potentially contaminated medical devices to the operating room.

All instruments must be inspected for bioburden to ensure a risk-free surgical instrument tray. Processing surgical trays must comply with all steps as directed by manufacturers in the IFU. Taking into consideration average times for reprocessing equipment and manual processes, depending on the tray and the number of instruments in the tray, it may take up to 3.8 hours to properly clean, prepare, sterilize, and transport a tray to the OR.

Properly reprocessing surgical instruments requires time, commitment, and patience to perform the job, according to the validations manufacturers submitted to the FDA. We all want to have a high-volume OR, but without an adequate number of instrument sets and reprocessing equipment, we are only putting patients at risk when we require SPDs to perform a rapid turnover of instrumentation. There is no such thing as a rapid turnover process, as all medical devices must adhere to the steps set by device manufacturers in their IFUs.

Perhaps the right approach to processing trays without placing patients at risk is to prioritize, meaning process first without skipping essential steps, and allow the SPD technician to complete the process without compromising the sterility of the set. But the best solution of all is to assess the number of procedures performed versus the number of instrument sets available and schedule surgical procedures accordingly.

References

  1. “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices,” Centers for Disease Control and Prevention, last modified October 2, 2015, https://emergency.cdc.gov/han/han00382.asp
  2. Karl Storz SE & Co. KG, Reprocessing instructions: Cystoscope Sheath, 9 Fr., 27033D, v. 1.1, February 2021, https://www.karlstorz.com/de/en/eifu.htm?id=27033D&language=en&country=de
  3. 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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