Medical Devices

HIT: Medical Devices

Overview

In a typical intensive care unit (ICU), a patient may be connected to one or more vital-sign monitors, receive fluids through infusion pumps, and be supported by a ventilator.Each of these medical devices has the ability to capture voluminous data, available per patient and multiple times per second. Today, these devices do not communicate and have little or no plug-and-play interoperability.This project is developing conformance tools and tests that will improve medical device communication standards, which enable devices to interoperate and electronically capture and process data between devices, thus leading to improved healthcare delivery and patient safety.

Industry Need Addressed

The Institute of Medicine report, "To Err is Human" estimates that 44,000 to 98,000 hospitalized patients die annually in the U.S. as a result of error. An analysis conducted by the West Health Institute, shows that the delivery of quality patient care could be enhanced and made dramatically more affordable by medical device interoperability. Analysis suggests "that true functional medical device interoperability improves patient care, increases efficiency, and results in more than $30 billion a year in health care savings."Interoperability among devices in an ICU can prevent medical errors. Due to the lack of standards for medical devices: (a) manually captured data is labor intensive and prone to human error, (b) expensive custom connectivity equipment may only be used for patients with the highest acuity, (c) detection of patient problems, (e.g., adverse drug events) is hindered due to the inability to collect real-time data from multiple devices, and (d) vendors intending to communicate data between devices must develop specialized interfaces for each device.NIST helps develop standards for medical device communications to address these critical needs.

NIST Approach

NIST researchers are facilitating the development and adoption of standards for medical device communications throughout the healthcare enterprise, as well as integration into the electronic health record. NIST is actively developing medical device communication test methodologies and tools to enable consistent and correct communication between medical devices and device-gateways across the healthcare enterprise. This work serves to provide standards-based and rigorous validation of medical device communication through conformance leading to interoperability. Rigorous testing is essential to achieve multi-vendor and enterprise-wide interoperability and must be predicated on sufficiently specified medical device and enterprise-communication standards. NIST is developing and advancing software test tools to meet medical device-level communication requirements defined in x73 and enterprise/electronic health record level defined in the Health Level 7 (HL7) messaging standard.

Impact

NIST/ITL developed conformance test methodologies provide the medical device industry with necessary tools to ensure that critical devices properly implement the x73 and HL7 standards.Correct implementation of these standards will lead to plug-and-play devices, allowing clinicians to focus more on the patient and less on the devices, ultimately leading to a reduction in medical errors and the associated loss of life.