FDA clears Cerner CareAware iBus

Cerner has received US Food and Drug Administration (FDA) clearance for a new product that enables exchange of information between medical devices and electronic health records.

The new CareAware iBus is Cerner’s latest solution developed to enable medical devices, used to monitor vital signs in a patient’s home or point of care, to easily exchange data captured and recorded and connect it into the patient’s EHR.

CareAware iBus is said to be a true plug-and-play system that enable a wide range of medical devices to cap capture important information about patient health, but the information captured is often then held in disparate systems outside of the patient’s EHR.

Cerner says its CareAware device connectivity architecture makes it easy for medical devices to connect directly to the EHR, enabling bi-directional data sharing between medical devices and the patient record. The devices that can be connected range from vital signs monitors to infusion pumps and other therapeutic devices.

"For the last two decades Cerner has been an active leader in developing device connectivity solutions," said Tom Herzog, Cerner vice president for IT and healthcare devices.

Herzog added: “The CareAware iBus solution is an interoperable platform developed in conjunction with our clients and certified device partners to create a standard for medical device connectivity, interoperability and workflow transformation."

Cerner says CareAware iBus provides “true plug-and-play capabilities for connecting any medical device to any EHR system”. The company claims that once a medical device is connected to the Cerner CareAware iBus solution, it is immediately recognized and can begin transmitting data to the EHR.

The company says this level of connectivity places the EHR at the centre of all information created and stored on the patient. The solution also allows waveform data to be transmitted directly into the EHR.

The Cerner CareAware iBus technology also provides the ability to correlate and trend various sources of information including various waveforms, heart rate and blood pressure. This trending information allows clinicians to analyze the patient’s data in the context of other clinically relevant data for a specific time period.

Cerner says the solution will improve patient safety and streamline clinician workflow by reducing the need for clinicians to manually enter device data into an EHR. This helps reduce the chance for transcription-related errors. One single view of all patient data and vital signs will also ensure better informed clinicians.

Having received FDA 510(k) pre-market clearance, a classification for medical device approval, CareAware iBus is now available in the US and its territories.