How can you meet the demands of increasing surgical volume?

ASCs and hospitals have long struggled with the problem of providing one standard of care to each and every patient.

With increasing surgical volumes, healthcare organizations have an increasingly difficult time meeting the demands of medical device sterilization. Historically, it was customary for instrument trays that had been previously terminally sterilized to be reused again later in the day for other patients by subjecting them to immediate use steam sterilization (IUSS).

Utilizing an IUSS prepared product because it is convenient or there is insufficient instrumentation or because of the late arrival of vendor instrumentation are no longer acceptable explanations to regulators. Organizations continue to receive deficiencies from state DOH offices, accreditation organizations and CMS when IUSS is used in instances that are not urgent. However, with repeated citations with failure to correct this deficiency, an immediate jeopardy can be issued by the surveying organization. An immediate jeopardy determination from a CMS survey can threaten the ability to keep your organization CMS certified and in some specialties, especially in ophthalmology, it could mean the closure of the facility.

What to do?
In 2006, the ONE TRAY® Sealed Sterilization Container was cleared by the FDA to be used to hold temperature tolerant medical devices during steam sterilization cycles and then be stored.
Another rigid container system?

Not at all, packaging systems had not a breakthrough in technology since the 1970s. The development of a scientifically engineered product that moves steam better through the container to the hardest areas to sterilize in a rigid container system was a significant advancement. The design of the tray increases air flow volumes, allowing steam to quickly reach the lateral edges of the tray. Other containers require extended cycles because they struggle to move steam to the lateral edges. The staggered vent placement and angled floor design allows for efficient airflow into the tray.

Another feature of ONE TRAY® is that it is a sealed container. The cam lock mechanism works by pulling the lid channel into the base creating a seal at the lid to base interface. This design feature is important for sterility maintenance. Three single use filters, one in the lid and two in the base, are inserted into a tray with each use. These unique filters serve not only as a particulate barrier but also as a fluid barrier. Other filtered vent containers have filters that are only particulate barriers. Unique only to a ONE TRAY® in the healthcare marketplace, the FDA cleared this packaging system with no dry and cool time and storage.

Industry definitions
Staff involved in the processing of medical devices are familiar with the terms IUSS and terminal. What most staff do not know is that these terms are not used by the FDA. IUSS and terminal are definitions that are found in industry publications and guidelines.

As defined by AAMI, immediate-use steam sterilization is a “sterilization method that involves the shortest possible time between a sterilized item’s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use nor held from one case to another.”1 While terminal sterilization is a “process by which the product is sterilized within a sterile barrier system that permits storage for use at a later time.”2 The major difference between IUSS and terminal is one word, STORAGE and ONE TRAY® has a shelf life originating with the 2006 FDA clearance; by industry definition, medical devices sterilized in a ONE TRAY® are terminal.

Shelf life is another confusing industry term. Organizations have a choice that can be made when deciding their own internal policies and procedures. Event related sterility maintenance is based on the premise that sterilized items are considered sterile until an event occurs that renders it unsterile or compromised in any way. An expiration date is not indicated on the product. If expiratory dating is chosen, the expiration date is placed on the product, defining its estimated useful life. If the organization uses event related principles in its’ practice, then ONE TRAY® can be kept on the shelf for as long as it is not compromised or considered unsterile. Additional performance testing for the maintenance of sterility has been conducted and ONE TRAY® is validated at 365 days; if using expiratory dating then a ONE TRAY® should be reprocessed 365 days from the date of sterilization.

Clinical applications
Facilities use ONE TRAY® in their sterile steam processing of medical devices for three primary reasons:

√ Workflow improvements utilizing ONE TRAY® for loaner/consignment instrumentation
√ Decrease need to purchase redundant instrumentation
√ Eliminates IUSS

Staff can now react quickly to any changes or issues during the day schedule or addressing on call situations when dealing with emergent needs.

Add on cases with insufficient instrumentation can now be scheduled knowing that a timely solution is available with the use of ONE TRAY®

If vendor trays are delivered late, time from sterilizer door close to open typically is less than 25 minutes instead of the traditional 2-3 hours waiting for trays to be dried and cooled after the sterilization cycle.

It is common for wraps to be found torn when they are needed for a procedure or when using other container systems that are found to be wet. In both examples, ONE TRAY® provides the solution by assisting the processing and surgical teams with preventing lengthy delays or cancellations.

Reduction of purchasing redundant instrumentation is realized when using ONE TRAY® due to the ability to turn trays quicker. Replacing of older equipment at the end of its’ useful life can also be decreased as the inventory may now be enough when using ONE TRAY®

ONE TRAY® can eliminate all IUSS by providing a terminally prepared product in approximately the same amount of time that is required of an IUSS prepared product. IUSS logs are no longer needed when using a ONE TRAY®.

Do not allow wrapped trays and other containers with required dry and cool times, insufficient instrumentation, late arriving vendor trays, additional surgical volume to interfere with the surgical schedule. ONE TRAY® is the solution to keep your surgical schedule running smoothly.

Saving features: efficiency, effectiveness and economical benefits
ONE TRAY®’s major economic gain comes from the elimination of dry and cool times. Sterilizer use is decreased affording the ability to run additional cycles on a daily basis. With the absence of dry time, there is less energy and water consumption required. The absence of idle time with staff waiting for traditional trays to complete their required dry and cool times drives better employee productivity as staff members are able to be deployed for activities such as preparations for surgeries, department tasks, educational offerings and quality control.

ONE TRAY® ‘s processing kit contains the items needed for the sterilization of the tray. With all the components needed in a single package, there is a reduction in waste, especially decreasing the dollars spent specifically on the disposal of wraps.

ONE TRAY® Sealed Sterilization Containers are guaranteed for the life of the product to be free of functional defects in workmanship and materials when used normally as recommended for their intended purpose in conjunction with ONE TRAY® filters, tamper evident locks and deck plate. This guarantee will decrease an organization’s budget line for the repair and/or replacement of rigid container systems.

Patient safety is a chief focus for all healthcare providers. When medical devices are safely prepared and packaged for patient use in a terminal fashion, the entire processing and surgical teams can have increased confidence and trust in the sterilization process. Sterilization processes are complex. Education and competency in all phases of the sterilization process is a necessity. Many organizations have recognized this process as multifaceted and have initiated specific initiatives to streamline the sterilization process.

ONE TRAY® Sealed Sterilization Containers are the newest advancement in rigid container technology and are a major integral addition to many successful and safe, quality surgical programs. Organizations have a choice. Choose one standard of care for each and every patient that receives surgical care from your organization. ONE TRAY® affords an organization the opportunity to do it right every time.

1 (2017 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST79:2017, page 7)
2 (2017 Association for the Advancement of Medical Instrumentation ■ ANSI/AAMI ST79:2017, page10)

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