Shared Responsibility for Medical Devices

Network medical devices surely offer the potential to increase patient safety and efficiency in hospitals. Yet those advantages also come with a new set of challenges, one of which is: who will take responsibility that the integrated system performs as it is designed? After all, a network-enabled digital device by definition is not a standalone device, in which the device manufacturer takes full responsibility that it works properly. For the network device to function as a system, it requires the cooperation of the device manufacturer, as well as the IT vendor and the hospital organization in which it operates.

A new standard, IEC 80001, ratified last September by the International Electrotechnical Commission, offers some guidance on the issue. Medical devices connected to the enterprise infrastructure is a recent development, says Yadin David, principal at Biomedical Engineering Consultants LLC in Houston and sensor member of the IEEE, who has co-authored a handbook on the standard. Until recently, “you didn’t have medical devices connected to the enterprise infrastructure,” Yadin says. “Once you have one or more medical devices connected to this network, like a smart pump, you turn it into a medical device network that has accountability and responsibility” associated with it.

David says the responsibility and governance is described in IEC 800001, which offers guidance on who are the responsible parties, what they are responsible for, and how they can show they have met their accountability. He calls the document a “major breakthrough” in terms of who is responsible for what and why it’s important to look at the question of responsibility. He adds that providers would do well to get collaborative agreements with device manufacturers and vendors.

David notes that there are other standards that address medical devices and risk management, , but they are generally limited to single devices and patient safety. This is the first standard that looks at IT networks connected to one or more devices, he says. Significantly, the standard is not prescriptive. “It gives a menu of activities on governance and what needs to be done, but it doesn’t dictate specifically how to do it,” he says.

Networked medical devices will require collaboration between the hospital, device manufacturer and IT vendors, and the new standard provides a framework to allow that to happen.