Sterilization Standards and the Importance of Alignment

Standards help protect patient safety

What ST79 and ST77 tell us about working together

SteriTite container with UDI and set identifier

Last week’s blog on the importance of adequate sterilization dry time made me think about how industry and users collaborate for best practices. Alignment and trust are crucial to achieve desired outcomes, and Case Medical is a firm believer in supporting industry quality and standards.

Alignment to standards

AAMI working groups include manufacturers, users, consultants, and other interested parties that come together to define standards that all should follow. An example of this alignment can be seen in AAMI ST79, a user’s document, and ST77 the manufacturer's document, Containment devices for reusable medical device sterilization. Manufacturers are required to meet the standards of ST77 to clear their packaging devices with FDA before release to market. For example, the section below describing the need for, and rationale behind, dry time with terminal steam sterilization cycles is particularly relevant.

4.4.2.1 General Requirements

The design of containment devices intended for use in steam sterilization shall provide for adequate drying of contents… 

Rationale: For a terminal sterilization process, there should be no visible condensed moisture present in or on a containment device following any sterilization process because of the potential for recontamination. Condensed moisture may create a pathway for microorganisms to enter the containment device and recontaminate the instruments inside.

Terminal sterilization requires dry time

No Shortcuts

Dry time is crucial for sterilized containers and instruments that will be stored for later use. Moisture increases the risk of recontamination. Every step of instrument reprocessing seeks to minimize risk, to create the safest possible situation for patients.

Container choices

Case Medical provides options for your sterilization needs.

  • Universal containers for terminal sterilization: The SteriTite® Universal Sealed Container System is the most versatile, durable, and economically sound choice. With compatibility with all current sterilizers and devices, and clearance for 5- to 8-minute dry times for prevacuum steam cycles, SteriTite containers can provide terminal sterilization in just a few minutes more than a typical IUSS cycle.
  • Replace sterilization wrap to reduce dry times: Blue wrap is made of plastic fibers that take significantly longer to dry than aluminum. Consider SteriTite Containers which meet the requirements for compatibility, corrosion resistance, sterility maintenance and efficacy. You may want to reference ST77, Annex A, Medical device integration with rigid sterilization container system, for a critical assessments comparison tool. This guides industry when choosing packaging methods, such as transitioning from wrap to containers, and developing appropriate IFUs.

Best Practices and Safer Products

When you choose who to work with for your sterilization packaging options, or any of the other important supplies you use daily, one thing is non-negotiable: working together in support of patient safety. No shortcuts. No compromises.  Contact us now at info@casemed.com. We are here to help.