How close is FDA to regulating wireless networks as medical devices? Well, that depends on who answers the question.
FDA received reports of six patients dying and 44 more being injured as a result of IT-related problems last year. These numbers are in addition to 260 reports of malfunctions that had the potential to cause harm. CDRH director Jeffrey Shuren says that these reports may be the tip of the iceberg because they are entirely voluntary. Still, regulation would appear to be very far away.
But it also depends on whether current trends in data management and networking continue. Many medical devices at hospitals and clinics are managed on discrete, separate networks, in part for safety and security reasons. But it would be more convenient for IT administrators to consolidate the networks into a single system, especially if there are some wireless network options. The problem is that most infrastructures haven't been tested to see if these medical device networks can be supported.
Additionally, the recently approved IEC 80001-1 has to be part of the conversation. The standard focuses on patient data security and patient safety, among other elements. For example, it defines the risk management requirements for IT networks that incorporate medical devices and touches on EMC between electronic devices. Some say that IT folks may bristle at regulation though, because it would prevent them from making as many changes "willy-nilly" to the networks.
"I've been to meetings of biomedical engineers. If you ask them if there are any cases where IT has disrupted patient care, all their hands go up," says Karen Delvecchio, a systems designer at GE Healthcare. "Sometimes it happens during the network design phase. Or it could be patient monitors, or some kind of alarming system, and when you fire it up, something else breaks."
IEC 80001 can be very helpful for network designers, but is it enough? Or should FDA do more? —Lawrence Lloyd