Medical Device Testing
(www.nist.gov/medicaldevices/)
John J. Garguilo (john.garguilo@nist.gov)
Overview: In a typical intensive care unit (ICU), a patient may be connected to
one or more vital-sign monitors, be receiving other fluids through
multiple infusion pumps and be supported by a ventilator. Each of these medical devices has the ability to capture
volumes of data, available multiple times per second, on a per patient basis. Today, these devices are implemented as
stove-pipe applications, communicating only with the monitor to which it is connected, with no plug-and-play
interoperability. The IEEE 11073 Medical Device Communicaion Working Group is defining a set of standards to enable medical device communication.
The standards will enable acute and continuing care devices to interoperate and electronically capture and process
their data to optimize healthcare delivery and improve patient safety and clinical efficacy. This project seeks to
contribute to the medical device community by developing conformance tools and tests that will be used by vendors to
improve medical device implementations.
Industry Needs Addressed:
The Institute of Medicine report, "To Err is Human" estimates that 44,000 to 98,000 hospitalized patients
ie annually in the U.S. as a result of error. The lack of interoperability between bedside devices in an ICU
can lead to preventable medical errors and greater efficiencies. Due to the lack of standards for these medical
devices: (a) manually captured data is labor intensive, recorded infrequently 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 to which it interacts. To address this critical need, the IEEE
11073 Working Group is developing standards for medical device communications and the Integrated Health
Enterprise (IHE) Patient Care Devices (PCD) Domain is developing a framework for the integration of medical
device data into the electronic health record. The result of these efforts will provide clinicians with the
ability to easily link patient connected bedside medical devices to a single monitoring device or a computer
network, thus facilitating the efficient exchange of medical device and vital signs data throughout
the healthcare enterprise.
NIST/ITL Approach:
NIST/ITL are collaborating with medical device domain experts, mainly via the IEEE 11073
Working Group and the IHE PCD Domain, in the development of testing methodologies,
tools, and tests to facilitate the development and adoption of standards for communicating medical
device data throughout the healthcare enterprise as well as integrating it into the electronic health record.
In particular, NIST/ITL is developing a standards-based schema and test tools that contribute to the momentum
of the IHE-PCD domain which is built upon the IEEE 11073 standards.
Impact: NIST developed conformance test methodologies provide the medical device industry with necessary
tools to ensure that critical devices properly implement the IEEE 11073 medical device standards. Correct
implementation of these standards will likely lead to plug-and-play devices for a hospital intensive care unit,
thereby allowing clinicians to focus more on the patient and less on the devices. The ability to reliably and
effectively integrate data from a broad range of bedside devices will ultimately lead to a reduction in medical
errors and the associated loss of life.
| |
