In February, Synthes sent out a notification letter to users of its medical implants, instruments and cases. The company recently re-evaluated the sterilization guidelines associated with the use of their devices. Now, to provide a greater sterility assurance level (SAL) the recommended cycles are based on worst-case scenarios. Parameters for pre-vacuum cycles are set at a minimum of 4 minutes. Temperatures must be at least 270 degrees faranheit and the dry time should be 20 minutes or more. The resulting overkill guards against contamination and is based on AAMI performance expectations outlined in ST77:2006 and TIR12:2004.
The drying period is especially important to note since the actual time needed can vary depending on the materials and wrapping technique employed for instrument sets. Synthes advises end users to independently verify the adequacy of dry times for each application. Wet loads should be re-sterilized. The manufacturer also notes that the protocols for steam sterilization are only valid when instruments have been appropriately cleaned prior to loading. Additionally, the autoclave must be operating properly according to AAMI standards.
Customers processing the following Synthes parts should continue to use the older parameters until further notice:
306.710
304.754
304.688
304.760
304.771
304.686
These items are still being tested with the new guidelines and may be included at a later date. The company is in the process of re-labeling the rest of the product line to indicate updates to its recommendations. It should be noted that the 530.100 power drive is not included in this revamping since the type of steam sterilization being discussed would damage the device.
More About Synthes
This company specializes in creating implants and instruments for reconstructive surgery. They partner with the Association for the Study of Osteosynthesis to develop and test state-of-the-art devices that speed patient recovery time and reduce pain. The manufacturer runs several interrelated business units including Trauma, Power Tool, and Spine divisions. They boast a number of innovations in the biomaterials field including implants that can be absorbed into the body. Their non-fusion lumbar and cervical disc replacements are also considered cutting-edge.
The company has a 10 year history of expansion and mergers. In 1999, Synthes joined forces with Stratec to become a leading medical device distributor. Four years later, the corporation acquired Spine Solutions (and their patented Pro-Disc technology) and merged with Mathys. The result was a global osteosynthesis conglomerate. In 2006, Synthes acquired its current trademarks and much of its intellectual property from the AO Foundation’s commercial subsidiary.
Since that time, the company has gone on to purchase N Spine and Innomedic. These corporations focus on spinal treatments and medical application software respectively. As the population in technologically advanced countries continues to age, Global Synthes aims to serve an expanding patient base. They are also focused on meeting the needs of medical facilities via constant improvement of their product line. Staying abreast of current recommendations in the sterilization field is just one example of their attention to detail.
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