We know that electronic medical devices are sensitive to water, temperature and pressure. For example, when using our mobile phones, we protect them so that no liquid is spilled on them. Because we know that if the liquid reaches the electronic drives, the device will fail. Or when the weather is hot, we need to store our phone in a cooler place so that it does not get damaged. When the weather is cold, we take it to a warmer environment. A suitable humidity and temperature value is required for the healthy operation of electronic systems. Above or below these values, electronic components can easily fail. So, how challenging can the working conditions of electronic medical devices be?
Consider a electronic medical device; In order to be sterile before each surgery, it should be exposed to pressurized steam at 135°C for 1 hour, shape the hard bone surfaces during the surgery and wash with chemical waters to get rid of the blood and bone tissues that dry on it after the surgery. The name of these electronic medical devices is the surgical power tool systems used in the field of orthopedics and traumatology.
All surgical power tool systems must withstand the autoclave temperature of 135°C. After this process, the handpieces should be waited until they reach room temperature. However, there are a limited number of surgical power systems in hospitals according to the number of operations due to increasing costs. For this reason, a single device can enter sequential operations. This is not a fault of the device user, but an obligation.
In some cases, the hospital staff tries to cool the device by spraying it with a cooling spray because they want the device to cool quickly. The cooling spray quickly cools the outer surface of the device and the handpiece becomes grippable. But the internal temperature of the device is still above 100 degrees. When it is operated in this way, the device may be damaged.
For this reason, components resistant to high temperatures should be used in the electronic driver of the surgical power tools.
Surgical power tool systems with blood and tissue splashes on the surface need to be washed after surgery. If the blood and tissue dry on the devices as a result of waiting for a long time after the operation, it becomes very difficult to clean. For these reasons, surgical power tool systems should be cleaned within a maximum of 30 minutes after the operation.
Each surgical power tool system has specific washing instructions according to the degree of water protection (IP).
Sometimes, after the operations of patients with infectious diseases, the hospital staff responsible for the washing process may go out of the washing instructions to ensure that the device is completely cleaned.
For example, a device with an IPX4 water protection (protection against splashing only) can wash it in dense water under the tap or cleaned by immersing into chemical waters with an IPX6 degree (which can be washed under the tap or automatic washing machine).
The manufacturer must consider all risks when designing a device. For this reason, while determining the sterilization and washing conditions, it is taken into account that the infectious disease does not pass on to the hospital staff and other patients, and all stages are proven by tests. The fact that hospital personnel follow the usage and washing instructions is actually very important in terms of protecting him/her, the next patient and the device. Surgical power tool systems will be damaged when washed outside of the manufacturer’s wash instructions.
Surgical power tool systems are used with disposable surgical saw blades and drill bits. The savings made by considering the hospital or company budget primarily harms the patient and then the device.
In a knee replacement surgery performed with a blunt surgical saw blade, the patient’s bone surface will be damaged as the cutting process will be prolonged. At the same time, the high-power device will be exposed to an extra force when it encounters a blunt saw blade and bone. This leads to a reduction in the mechanical life of the device.
Effective communication between the manufacturer and the hospital is required in order to reveal the true lifetime of the devices. It is the responsibility of the hospital to determine the number of devices according to the number of operations; It is the manufacturer’s responsibility to take precautions against these difficult conditions.
Surgical power tool systems need a little more than the attention given to other electronic medical devices, as they are devices with high costs and difficult working conditions.
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Errors resulting from the cleaning process of surgical power tool systems not only pose risks to the patient. Users also have losses. In this article,
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.
