Medical devices are increasingly being networked, for example to populate the electronic health record (EHR). Problems with individual devices in such a system, or unexpected interactions between the devices, can cause device failures and may compromise patient safety. For example, in our lab we have documented a case of ventilator failure triggered by requesting data to send to the EHR. When this kind of incident occurs, clinicians, manufacturers, and regulators have the responsibility to investigate the cause of the problem and try to ensure that it does not happen again.
Planes, trains, and automobiles have “black box recorders” – or “data loggers” to support forensic data analysis in safety critical systems. We believe that this capability is essential for clinical environments as well. As described in standard ASTM F2761-09
on the Integrated Clinical Environment (ICE), even-logging functionality is necessary to address regulatory and liability concerns regarding networked medical device systems, and will also improve the forensic analysis of clinical adverse events and near misses.
When data from medical equipment is available in a suitable format for forensic data logging, the data can also be used to create novel data presentation displays, be provided to real-time or post-hoc analytics engines, and other applications to support clinical care.
We are implementing a basic open-source ICE Data Logger that will capture device and use data intended to facilitate analysis of adverse events and enable other types of analysis of device networks, and we plan to develop a functional prototype Data Logger that will capture data from medical devices in a time-synchronized, standardized, and trustworthy manner. This work will preview the power of these emerging capabilities, as existing standards do not yet support all the data that is needed from devices for recording and later analysis.
A prototype ICE Data Logger implemented by NIST based on OpenICE
was presented at the Smart America Expo June 2014 in the Closed Loop Healthcare