According to the agency’s safety communication, several medical devices contain configurable embedded computer systems that could be vulnerable to cybersecurity attacks.
Besides, as these devices are increasingly interconnected, via the internet, hospital networks, other medical device, and smartphones, there is a growing risk of cybersecurity attacks, which could hamper in how a medical device works.
The FDA, however, said that it is not currently aware of any patient injuries or deaths linked with such attacks nor there is any indication that any specific device in clinical use has been purposely targeted.
The agency told manufacturers that they are responsible for remaining vigilant about identifying such risks with their devices, and having appropriate mitigations in place in order to address patient safety and assure proper performance of the devices.
The FDA said that it is working closely with other federal agencies and manufacturers to identify, communicate and reduce such vulnerabilities.
It has urged manufacturers to review their cybersecurity practices and policies to assure that appropriate safeguards are in place.
