Medical Device Testing

In a typical intensive care unit (ICU), a patient may be connected to one or more vital-sign monitors and be receiving medicine or other fluids through multiple infusion pumps. More acutely-ill patients may also be supported by devices such as ventilators, defibrillators or hemodialysis machines. Each of these medical devices has the ability to capture volumes of data, available multiple times per second, on a per patient basis. These devices are implemented as stove-pipe applications, communicating only with the monitor to which it is connected, with no plug-and-play interoperability.

To address this critical need, the IEEE 1073 Working Group has developed a set of standards for medical device communications. Vendors are beginning to implement these standards in their devices. Implementations of these standards will provide clinicians with the ability to link patient connected medical devices to a bedside patient monitoring device or a computer network in a simple fashion. This permits comprehensive data capture from devices such as infusion pumps, ventilators, and vital-sign monitors connected to acutely ill patients.

NIST/ITL is collaborating with the IEEE Medical Device Communications working group in developing conformance tests and associated tools to provide the medical device industry with the necessary tools to ensure that critical devices properly implement the medical device standards. As part of this effort NIST has developed a tool called ValidatePDU, to validate the basic syntax and structure of messages, converted the ASN.1 definitions from the IEEE specification into XML Schema files, and is designing and generating test cases. Initally, the approach focuses on basic discovery, management and association fuctions for ventilators and patient monitors. Ultimately, the work will be expanded to address dynamic behaviors such as alarm reporting, event reporting and scanners as well as additional medical devices.

Downloads

IHE Open Source Project: XDS software (html file)

Message Maker Prototype (html file)

Healthcare Standards Landscape (html file)

Healthcare Information Standards and Testing, A Concept Paper (pdf file)

Conformance Testing and Certification Framework, White Paper (pdf file)

What is This Thing Called Conformance, White Paper (html file)

Principles for Writing Conformance Criteria (pdf file)

Building HL7 EHR-S Conformance Criteria, Slide presentation (html file)