Why is autoclave validation important in the life cycle of Surgical Power Tool Systems?

Surgical Power Tool Systems are devices that complete their preparation for use by sterilising at 135 degrees due to their area of use and design.

Pre-clinical performance studies on heat resistance start at the design stage, and the tolerance in the plus and minus direction is calculated to be 4 degrees. The accuracy of autoclave devices, which are expected to operate at equivalent temperature ranges according to the standard, is made by hospitals according to the planned validation frequency according to the frequency of operation and risks.

However, due to reasons such as the frequency of validation work is not calculated correctly or the correctly calculated validation work is not carried out on time, the devices sterilised in an autoclave performing above the planned temperature during the design phase of the surgical power tool systems are at risk of deterioration.

If the surgical power tool, which is checked before the operation, is sterilised in an unvalidated autoclave, it will be damaged and it will be understood that it does not work before the operation.

The loss of time with the sterilisation time of a new device and the continuation of the risk of deterioration of the other working device due to the same autoclave can put the whole team under high stress. Another reason for the high stress of the team is that the patient receives more anaesthesia than planned, which is a process in which the patient will face other risks beyond the surgical operation. The time and cost of verification studies are inversely proportional to the high risks. In the planned periods, hospitals can carry out verification studies from their own bodies with a heat-resistant thermometer that can be placed in the machine before the autoclave, and in case of a possible mishap, they can request technical service from the autoclave manufacturer. With this study, the lifetime of the autoclave device is extended, the robustness of all sterilised devices is ensured and risks are eliminated.

The risks that we can eliminate with the validation of the sterilisation device are in the best interest of the surgical team and the patient. In medical device design, ensuring the stability of performance values expressed in numbers ensures the stable operation of all devices that can work in the final area with the support of each other, and at the end of the day, the success of the surgery, that is, the stability of the success of the hospital and the team. Making sure that verified devices meet with the team in surgical operations is a burden of human conscience far beyond the return of professionalism.

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