In the absence of true standards of medical device communication, medical device integration is a proven, reliable solution for accurate and timely delivery of those data to the various systems and applications running throughout a healthcare organization. While some device manufacturers develop interfaces to some common standards for point-to-point medical device integration, not all have achieved it. There are barriers and limitations they must first overcome before we see all devices use the same protocols and communicate in the same formats. In addition, hospitals today have legacy equipment that still function well and could very well remain operational for a long period of time.
These realities necessitate, for now and the immediate future, the continued use of third-party medical device integrators. Medical device integration (MDI) is the process of automating the integration of data from multiple point-of-care devices into various information systems, such electronic medical records (EMRs), alarm and alert systems, predictive analytics, clinical decision support systems, or other similar departmental solutions. MDI means that all devices do not need to share a common interface or device protocol—the integrator serves that function.
Device Drivers Are Essential to Data Accuracy
Device drivers (also known as device data interfaces or DDIs) are the “translators” that receive device-specific data and transform those data into a unified format. They are the most challenging component to design. Correct development is absolutely essential to ensuring patient safety because of the critical need for accuracy of the information sent to an EMR and other systems. As Class C software components, driver development is ideally steered by FDA guidelines with stringent risk management and design controls.
Medical Device Integration Vendors Are Device Manufacturer Allies
Vendor-neutral medical device integrators partner closely with device manufacturers to ensure driver compatibility with each device firmware upgrade and/or release, in addition to regular maintenance of older versions. Stringent validation processes, the experience of evaluating same device types and drivers for different manufacturers, plus the expertise in working with clinical requirements of the data from individual hospitals, all provide a third-party integrator with a thorough understanding of how device data is being used. This partnership not only benefits the downstream systems that clinicians use to view data (EMRs, alarms and alerts, etc.), but also benefits the device manufacturers by assisting to identify anomalies in their protocols based on common utilization of the data.
Worst Case Scenario
Although device drivers are developed based on a device manufacturer’s specific standards, unforeseen results still occur. An improperly functioning driver or an unexpected device reaction can result in risks that include:
Downtime: If a driver does not operate as expected, hospital workflow is impeded while connectivity temporarily ceases for modification.
Reporting: Incorrect device data may be sent to an information system, potentially adding improper information to the patient’s record, triggering a false alarm, or even sending no device data at all.
Malfunction: An unexpected reaction or glitch may be possible, causing the device to function improperly, such as recording incorrect patient measurements, or incorrectly delivering vital functions such as breathing assistance at improper intervals. In a more severe scenario, a risk can include a device shutdown as a result of an untested driver or lack of device sophistication.
There Is a Bright Side
These risks are a concern to all those using or evaluating an MDI solution. However, they can easily be mitigated by proper device driver development, working closely with the device manufacturer, and implementing proper verification and validation in a testing environment. By partnering with medical device integration vendors, device manufacturers have an additional layer of testing to validate their protocols before releasing it for clinical use. This ensures that electronic documentation of their devices’ data is accurate and that they are, in fact, supporting safe patient care.
This article was written by Sylvain Jolibert, Verification and Validation Manager at Capsule Tech, Inc., Andover, MA. For more information, Click Here .