Recently, Synthes has sent out a letter to all customers and to the industry to give their approval for using sterilization containers in lieu of disposable or reusable wrap for packaging of their non-sterile custom graphic sets “loaners”.
The letter states,
“To date, Synthes’ recommended processing instructions for non-sterile devices have only applied to the use of woven and non-woven sterilization wrap materials, which are widely used in healthcare facilities. In order to provide more options to hospitals, Synthes has now included rigid sterilization containers in our recommended processing instructions for non-sterile implants and reusable medical devices.
Sterilization parameters for non-sterile devices detailed in current labeling (device specific inserts, generic inserts, technique guides, etc.) will remain the same and are validated for use with wrap or rigid sterilization containers. The labeling contains validated recommendations for Cycle Type, Minimum Exposure Time, Minimum Exposure Temperature and Minimum Dry Time that are applicable to all devices cleared by FDA as sterilization wraps, including rigid sterilization containers.
Our current cleaning and sterilization instructions for use (Processing Synthes Reusable Medical Devices and Processing Non-sterile Synthes’ Implants) have been updated to state the following:
“Only legally marketed, FDA-cleared sterilization barriers (e.g., wraps, pouches, containers) should be used by the end-user for packaging terminally sterilized devices.”
…Detailed processing instructions for Synthes non-sterile implants and reusable medical devices, as well as the instructions outlined in the formal hospital letter, must be followed to ensure proper sterilization of the devices.”
As you know, Case Medical has been working with orthopedic companies and other major medical suppliers to allow for containerization of their “loaners.” In fact, Case Medical started, nearly 20 years ago, as a manufacturer of custom graphics trays for orthopedic instrument sets. We developed our SteriTite universal, DIN sized container originally for this purpose.
Over the years, we have been asked by many users to help containerize “loaners” and get the word out to orthopedic vendors. Our mutual goal was to avoid tears in the wrappers, address reprocessing issues, delayed cases, and support your efforts to return to standard cycles and improve the way your products are organized and packaged.
Case Medical has actively participated in the AAMI working group focusing on containment devices – ST77, and contributed to the new Annex A providing a protocol for integration from wrapped custom sets to containers.
Please use this information as a guide. Let us know how we can help facilitate the transition. Call (201) 313-1999 ext. 206 for more info or click here.