Rigid reusable sterilization container systems are commonly used in the US and even more so in Europe, and numbers are growing. Both the sterilization method utilized and the parameters set are similar to those for wrap. However, container systems provide some significant advantages including reduced reprocessing and cycle times, no torn wrappers, reduction in wet packs and improved ergonomics. Reusable products also save time and money, are environmentally preferred and can meet the goal of achieving standard hospital cycles. According to AAMI ST79 Annex J, “A delay in heat up time is not seen in container systems processed in a pre-vacuum cycle.”
While hospitals transition their sets from wrap to rigid reusable sealed containers, many have also decided to move their custom wrapped trays graphics trays to containers. Nonetheless there has been much confusion and discussion about how to do this and whether this transition falls under FDA regulations. IFU’s from medical device manufacturers do not necessarily indicate whether wrap, container or unwrapped trays should be used for packaging of these devices or instrument sets.
This discussion was a hot topic at AAMI last week in both the ST77 and ST79 working groups. ST77 is a manufacturer’s document on containment devices while ST79 is a guidance document for users.
According to FDA officials who shared their opinions:
Guidelines help sterile processing personnel make correct and educated decisions in the field. Device manufacturers are not required to mention a specific device used for validation, only parameters. AAMImay offer advice to users on choosing a wide variety of cleared FDA sterilization accessories.The important issue here is whether the container and tray as well as the device share common labeling and are FDA cleared.
Case Medical has worked with medical device companies over the past 20 years to design and manufacture custom graphics trays for specialty devices. The company’s SteriTite container was designed specifically for containerizing custom trays, commonly called “loaners”. Our container and accessories have been cleared for all current sterilization modalities and medical devices based on manufacturer’s instructions.
Additionally, please mark your calender for our next free online educational program on June 19, 2012. Nancy Chobin will be leading the discussion on Hospital Acquired Infections and Prevention. We will be sending registration information for the webinar shortly.