Draft Standard for Risk Management of Medical Devices in Networks - An Answer to Our Problems

Medical device manufacturers\´ processes and designs are regulated, ensuring that designs meet the required standards before products are sold. When medical devices were used in isolation, these methods gave confidence but those days are gone. Medical devices are frequently combined to create systems. Such systems produce behaviour which the device designers cannot anticipate. Now connection to hospital networks has finally created a recognised crisis with virus attacks, data loss, safety incidents and security breaches. Unregulated "post sales design" is being done in the hospital largely without safety engineering. This paper introduces a new standard that addresses the question "who is the system safety engineer?" for medical devices connected to hospital networks.