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Product Testing: The Why's and How-Tos in Sterile Processing

Updated: Mar 10, 2022


Product testing in sterile processing is one of the most misunderstood processes. Most professionals do not know how to complete the process or when it should occur. The idea of creating a product testing protocol came along with the advent of the rigid sterilization container. The design of the process has mostly remained the same. The rub is that some manufacturers provide no information on how to complete the process while others direct you to AAMI documents, and AAMI directs you to the manufacturer.


Where do We Start?


A good question, indeed. Let's start with the AAMI ST79:2017 statement 13.10.2.1 General considerations: Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a rigid sterilization container system, is suitable for use in sterilization processing and sterility maintenance. So there you go, we are responsible for verifying that the products we are using in our sterilization department function as the manufacturer intends. Variables are great, from the delivery of the steam to the tray/package design and the growing number of sterilizer manufacturers that we can purchase from. There is no way a packaging manufacturer can validate them all. The onus lies with us.


When Should This Occur?


Ideally, before we start using the product. I don't know about you, but I do not favor sterilization recalls! If you haven't started product testing before its use, time is of the essence. The development of product families must first occur along with master products, and there are other caveats to the process. In the AAMI ST79:2017 document, the association states in section 13.9 Periodic product quality assurance testing of routinely processed items: 13.9.1 General considerations

...It is not necessary to conduct product testing of medical devices on an ongoing basis, unless recommended by the applicable manufacturer. One caveat is that if you master product changes, you need to retest.


Why Should This Occur?


Simply put, this is a part of a sterile processing department's quality assurance program. If you are not sure that sterilization occurs inside your packages, you shouldn't be sending them to the OR for use. Another issue can be condensation, which can contaminate the product while it sits in storage.


How Do I Test My Products?


To keep you from reading a lengthy blog that will do nothing but regurgitate documentation that has already been written, I will direct you to two sources to read:


  1. ANSI/AAMI ST79: 2017 sections 13.9, 15.0, and Annex H

I prefer option 2, but it is all excellent information.



The Last Word


Not to be forgotten, as I am sure you will learn a lot from the sources above, when constructing a new sterile processing department or sterilization space, make sure you plan the time to complete your product testing before you launch the opening.



At Evolved Sterile Processing, our consultants have a greater focus on sterile processing. With our decades of experience, we will help you develop better processes and educational resources for your staff.




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