Page 175 - Safety Risk Management for Medical Devices

154 Safety Risk Management for Medical Devices

Figure 16.6 Failure Mode of the Water Pump.

Figure 16.7 Failure Mode of the engine.

The same construct can continue upward to the car-level, where the End Effect of
Engine Stops at the engine level can become the Failure Mode of the engine from the
perspective of the car. Again, what was the End Effect: Engine Stops from the engine
perspective, becomes the Failure Mode of the engine from the car perspective, which
sees the engine as a black box component. Fig. 16.7 illustrates the engine as a black
box from the perspective of the car.

16.2 INTEGRATION OF SUPPLIER INPUT INTO RISK MANAGEMENT

Most medical device manufacturers use suppliers to produce parts of their medical
devices. The design and manufacturing of the supplied parts plays a role in the safety
of the medical device. The input from the suppliers must be incorporated in the risk
management of the medical device.
At a minimum, what is needed from suppliers are the Failure Modes of the products
that they supply, and the occurrence ratings of the Failure Modes. With that information,