Medin Corporation: OEM: 501(k)

There has been some attention given over the past few months to assertions by a tray manufacturer that all instrument trays such as those manufactured by Medin Corporation require a 510(k) as a Class II Medical Device. We believe that much of the information that has been circulated and/or published is ambiguous or incorrect.

In fact, the trays manufactured by Medin Corporation are intended to be used with an over-wrap or placed into a sterilization container with filters or valves for the express purpose of sterilizing the contents and maintaining sterility. It is not possible for instrument trays to maintain sterility of the contents by themselves because they are not manufactured for the purpose of providing a barrier for a sterile environment. That is why they must be used with over-wraps or placed in a closed sterilization container that maintains sterility. Moreover, it is not possible for a manufacturer of instrument trays to make claims about sterility when the eventual contents are not known.

It would seem to us that the end user would be best equipped to assess the efficacy of their own sterilization process by utilizing current published standards in concert with standards developed in-house on site. It is not possible for us to instruct customers because we do not know what the contents or eventual use of the tray will be. Consequently, we feel that the claim that we require a 510(k) is misguided and intended to advance other purposes.

True validation testing can only be accomplished once all of the intended components are identified and all of the contents are brought together and assembled. Additionally, the testing needs to be performed with an over-wrap or sterilization container for the intended purpose of sterilizing the contents. The end user normally develops procedures and standards to accomplish this. Certain biological and chemical parameters are used to validate the process as directed by internal standards and procedures at the end-user’s facility. The manufacturer has no control over these functions.

We will continue to work with our customers and others in our marketplace to ensure that this issue is correctly and properly addressed and we will offer continuing support and education to the benefit of all in our industry. Our commitment to you and the industry is a total quality commitment to exceed expectations for quality, design, and delivery.